Milex
KIT: Hodge with support with knob folding Pessary #2; 3 1/4" x 1 15/16" (83mm x 49mm)
4manufacturers in China registered for this device type
592catalogue numbers in this listing
1510(k) clearance
15recalls on this code
Who Else Makes It
All of them in Guangdong. 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| B&A Precision Silicone Rubber (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Guangzhou Fame Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 1 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
Record
| Listed by | Coopersurgical, Inc., United States |
|---|---|
| FDA product code | HHW |
| Device type | Pessary, Vaginal |
| Device class | Class 2 |
| Regulation | 21 CFR 884.3575 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K904026 |
| Record published | 2025-10-10 |
| Record revised | 2024-02-28 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MXPGSS2-1/4 | In distribution | |
| MXKPEC00 | In distribution | |
| MXPEHK06 | In distribution | |
| MXPCON01 | In distribution | |
| MXPES04 | In distribution | |
| MXPHS00 | In distribution | |
| MXPRSK02 | In distribution | |
| MXPSH3- | In distribution | |
| MXPERK04 | In distribution | |
| MXPSH3- | In distribution | |
| MXPDO02 | In distribution | |
| MXPRSK08 | In distribution | |
| MXKPGRS3- | In distribution | |
| MXPEH09 | In distribution | |
| MXPRSK04 | In distribution | |
| MXKPRSK04 | In distribution | |
| MXKPGE2-3/4 | In distribution | |
| MXPRS03 | In distribution | |
| MXKPREG03 | In distribution | |
| MXPSH2- | In distribution | |
| MXKPHSK00 | In distribution | |
| MXKPEH00 | In distribution | |
| MXKPGE2- | In distribution | |
| MXKPHSK04 | In distribution | |
| MXKPCONDS06 | In distribution | |
| MXKPECT7-5 | In distribution | |
| MXKPERK6 | In distribution | |
| MXKPGE1-3/4 | In distribution | |
| MXPCONDS02 | In distribution | |
| MXPGSK00 | In distribution | |
| MXPREG01 | In distribution | |
| MXKPGSS1-3/4 | In distribution | |
| MXPGRS3-1/4 | In distribution | |
| MXPGS04 | In distribution | |
| MXKPSH3-1/2 | In distribution | |
| MXPGSS1-3/4 | In distribution | |
| MXKPRS08 | In distribution | |
| MXKPRSK09 | In distribution | |
| MXPSH2- | In distribution | |
| MXPCOND05 | In distribution | |
| MXPERK13 | In distribution | |
| MXPEH08 | In distribution | |
| MXKPRS11 | In distribution | |
| MXFIT0804 | In distribution | |
| MXPGE3-3/4 | In distribution | |
| MXPGE1-1/2 | In distribution | |
| MXKPEC02 | In distribution | |
| MXPGE1-3/4 | In distribution | |
| MXPGSS1-1/2 | In distribution | |
| MXPRI03 | In distribution | |
| MXFIT0024 | In distribution | |
| MXPEH00 | In distribution | |
| MXPER00 | In distribution | |
| MXPREG05 | In distribution | |
| MXKPRSK12 | In distribution | |
| MXPECH02 | In distribution | |
| MXKPEH06 | In distribution | |
| MXKPGE2-1/2 | In distribution | |
| MXPGE3- | In distribution | |
| MXKPGE3-1/2 | In distribution | |
| MXPGS02 | In distribution | |
| MXKPCOND02 | In distribution | |
| MXPGRS1-1/2 | In distribution | |
| MXKPCOND04 | In distribution | |
| MXPHSK09 | In distribution | |
| MXPINFS | In distribution | |
| MXPER08 | In distribution | |
| MXPERK01 | In distribution | |
| MXPER01 | In distribution | |
| MXFIT0025 | In distribution | |
| MXPERK01 | In distribution | |
| MXKPRSK03 | In distribution | |
| MXPRS04 | In distribution | |
| MXPGSK07 | In distribution | |
| MXKPCON10 | In distribution | |
| MXKPREG07 | In distribution | |
| MXKPECT4-2 | In distribution | |
| MXKPREG01 | In distribution | |
| MXKPERK0 | In distribution | |
| MXPCON05 | In distribution | |
| MXPERK03 | In distribution | |
| MXKPDO06 | In distribution | |
| MXKPRSK08 | In distribution | |
| MXPERK10 | In distribution | |
| MXKPRI00 | In distribution | |
| MXREAL | In distribution | |
| MXPRI04 | In distribution | |
| MXKPRS13 | In distribution | |
| MXPER03 | In distribution | |
| MXPHS07 | In distribution | |
| MXKPCON08 | In distribution | |
| MXPHSK05 | In distribution | |
| MXPRS09 | In distribution | |
| MXPGSS3- | In distribution | |
| MXKPGS02 | In distribution | |
| MXPREG06 | In distribution | |
| MXPGSS2-3/4 | In distribution | |
| MXPRI01 | In distribution | |
| MXFIT0022 | In distribution | |
| MXPGE2-1/4 | In distribution | |
| MXPGE2-1/2 | In distribution | |
| MXFIT | In distribution | |
| MXPERK00 | In distribution | |
| MXPGRS2- | In distribution | |
| MXPRS05 | In distribution | |
| MXPES09 | In distribution | |
| MXFIT0018 | In distribution | |
| MXPSH3-1/2 | In distribution | |
| MXKPER13 | In distribution | |
| MXPRSK06 | In distribution | |
| MXKPCON02 | In distribution | |
| MXPCONDS00 | In distribution | |
| MXPGRS3- | In distribution | |
| MXPRSK12 | In distribution | |
| MXKPREG04 | In distribution | |
| MXKPER08 | In distribution | |
| MXPSH3-1/4 | In distribution | |
| MXPRS07 | In distribution | |
| MXPEH05 | In distribution | |
| MXPGE2-1/2 | In distribution | |
| MXPCON07 | In distribution | |
| MXKPGSK09 | In distribution | |
| MXKPSH2-3/4 | In distribution | |
| MXKPRI02 | In distribution | |
| MXKPERK4 | In distribution | |
| MXKPEHK08 | In distribution | |
| MXPGRS2-1/4 | In distribution | |
| MXPGSS2- | In distribution | |
| MXPER03 | In distribution | |
| MXKPGS01 | In distribution | |
| MXKPRS02 | In distribution | |
| MXKPGRS2-3/4 | In distribution | |
| MXPRSK11 | In distribution | |
| MXKPEHK02 | In distribution | |
| MXKPCON11 | In distribution | |
| MXPER07 | In distribution | |
| MXFIT0017 | In distribution | |
| MXKPEHK09 | In distribution | |
| MXPRI08 | In distribution | |
| MXKPES01 | In distribution | |
| MXPSH3-3/4 | In distribution | |
| MXKPECT3-1 | In distribution | |
| MXPEC07 | In distribution | |
| MXPER12 | In distribution | |
| MXPDO0 | In distribution | |
| MXPSH3-1/2 | In distribution | |
| MXKPCON07 | In distribution | |
| MXKPCON00 | In distribution | |
| MXPES08 | In distribution | |
| MXKPHS06 | In distribution | |
| MXKPGRS2- | In distribution | |
| MXKPHSK05 | In distribution | |
| MXPRS13 | In distribution | |
| MXPGE1-3/4 | In distribution | |
| MXPCON13 | In distribution | |
| MXKPRS00 | In distribution | |
| MXKPES07 | In distribution | |
| MXPGSS2- | In distribution | |
| MXKPGE1-1/2 | In distribution | |
| MXFIT0023 | In distribution | |
| MXKPES05 | In distribution | |
| MXKPRI08 | In distribution | |
| MXFIT0805 | In distribution | |
| MXKPERK7 | In distribution | |
| MXPRS08 | In distribution | |
| MXKPCOND06 | In distribution | |
| MXPEHK03 | In distribution | |
| MXKPRS06 | In distribution | |
| MXPES02 | In distribution | |
| MXKPEH05 | In distribution | |
| MXPRS01 | In distribution | |
| MXKPRSK02 | In distribution | |
| MXPRSK09 | In distribution | |
| MXKPHS03 | In distribution | |
| MXPGE1-1/2 | In distribution | |
| MXPGE3-1/2 | In distribution | |
| MXKPECH03 | In distribution | |
| MXKPRSK00 | In distribution | |
| MXKPGSS3-3/4 | In distribution | |
| MXPCOND03 | In distribution | |
| MXKPRS07 | In distribution | |
| MXPCON12 | In distribution | |
| MXPCON02 | In distribution | |
| MXPDO05 | In distribution | |
| MXPGE3-1/4 | In distribution | |
| MXPRSK10 | In distribution | |
| MXKPGRS3-1/4 | In distribution | |
| MXPGS03 | In distribution | |
| MXPECH04 | In distribution | |
| MXFIT0810 | In distribution | |
| MXPRSK13 | In distribution | |
| MXPGE2-3/4 | In distribution | |
| MXPEC06 | In distribution | |
| MXPHS03 | In distribution | |
| MXKPCOND03 | In distribution | |
| MXPGRS1-3/4 | In distribution | |
| MXKPHS00 | In distribution | |
| MXKPGS00 | In distribution | |
| MXPRSK09 | In distribution | |
| MXKPRS09 | In distribution | |
| MXPGS06 | In distribution | |
| MXPEHK05 | In distribution | |
| MXPHS05 | In distribution | |
| MXPECT2-0 | In distribution | |
| MXPREG00 | In distribution | |
| MXKPERK8 | In distribution | |
| MXPECT3-1 | In distribution | |
| MXFIT0020 | In distribution | |
| MXPECH06 | In distribution | |
| MXKPEC03 | In distribution | |
| MXKPER03 | In distribution | |
| MXPGSS2-1/2 | In distribution | |
| MXKPHSK08 | In distribution | |
| MXPGSS2-1/4 | In distribution | |
| MXKPECH04 | In distribution | |
| MXPGSS2-1/2 | In distribution | |
| MXKPHSK02 | In distribution | |
| MXKPHS05 | In distribution | |
| MXKPECH02 | In distribution | |
| MXPRS12 | In distribution | |
| MXKPGSK03 | In distribution | |
| MXKPEH07 | In distribution | |
| MXPECH00 | In distribution | |
| MXKPHS01 | In distribution | |
| MXPECT7-5 | In distribution | |
| MXPRI05 | In distribution | |
| MXPCON04 | In distribution | |
| MXKPINFL | In distribution | |
| MXKPRSK07 | In distribution | |
| MXPCON11 | In distribution | |
| MXPERK05 | In distribution | |
| MXPER02 | In distribution | |
| MXKPES08 | In distribution | |
| MXPRI00 | In distribution | |
| MXPRSK08 | In distribution | |
| MXPRSK06 | In distribution | |
| MXPCONDS06 | In distribution | |
| MXKPHS07 | In distribution | |
| MXPGE2-1/4 | In distribution | |
| MXKPHS09 | In distribution | |
| MXPEC05 | In distribution | |
| MXPER10 | In distribution | |
| MXPGSS2-3/4 | In distribution | |
| MXKPCOND00 | In distribution | |
| MXKPCON03 | In distribution | |
| MXKPERK11 | In distribution | |
| MXKPSH3- | In distribution | |
| MXPRS06 | In distribution | |
| MXPRS06 | In distribution | |
| MXPHS01 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pessary, Vaginal | Panpac Medical Corporation | 628 |
| Bioteque America, Inc. | Bioteque America, Inc. | 221 |
| Bioteque | Bioteque Taiwan Ltd. | 209 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 189 |
| HNM Women Care | HNM Stainless, LLC. | 187 |
| Medline | Medline Industries, Inc. | 162 |
| Marina Medical | Marina Medical Instruments, Inc. | 144 |
| EvaCare | Personal Medical Corp. | 128 |
| Hayden Medical | Hayden Medical Inc | 81 |
| Premier | Premier Dental Products Co. | 58 |
| LTL Medical | Bioteque Taiwan Ltd. | 56 |
| Sklar® | Sklar Corporation | 37 |
Showing 12 of 180. All products under Pessary, Vaginal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K250438 | 2025-04-11 |
Recalls Naming This Product
13 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Coopersurgical, Inc. | 510(k) number | 2017-04-10 | Class II | Error in labeling | The current secondary packaging, a box, incorrectly states that the product is latex free. The product is made with 100% latex. The label on the package that contains the product and the Instructions for Use (IFU) correctly states that the | 7126 units (total for all products) | 2017-11-01 |
| Coopersurgical, Inc. | 510(k) number | 2015-02-09 | Class II | Error in labeling | Incorrect size printed on the Milex Pessary Kit packaging label | 95 units | 2016-01-15 |
| Coopersurgical, Inc. | 510(k) number | 2014-09-30 | Class III | Incorrect or no expiration date | Incorrect expiration date printed on the MILEX PESSARY KIT packaging | 17 units | 2015-05-28 |
| Coopersurgical, Inc. | 510(k) number | 2014-09-30 | Class III | Incorrect or no expiration date | Incorrect expiration date printed on the MILEX PESSARY KIT packaging | 6 units | 2015-05-28 |
| Coopersurgical, Inc. | 510(k) number | 2013-02-26 | Class III | Packaging process control | Pessary mislabeled outer package may not reflect the size of the product contained in the package | 80 units | 2014-03-04 |
| Coopersurgical, Inc. | 510(k) number | 2013-02-26 | Class III | Packaging process control | Pessary mislabeled outer package may not reflect the size of the product contained in the package | 18 units | 2014-03-04 |
| Coopersurgical, Inc. | 510(k) number | 2013-02-26 | Class III | Packaging process control | Pessary mislabeled outer package may not reflect the size of the product contained in the package | 45 units | 2014-03-04 |
| Coopersurgical, Inc. | 510(k) number | 2013-02-26 | Class III | Packaging process control | Pessary mislabeled outer package may not reflect the size of the product contained in the package | 36 units | 2014-03-04 |
| Coopersurgical, Inc. | 510(k) number | 2013-02-26 | Class III | Packaging process control | Pessary mislabeled outer package may not reflect the size of the product contained in the package | 31 units | 2014-03-04 |
| Coopersurgical, Inc. | 510(k) number | 2013-02-26 | Class III | Packaging process control | Pessary mislabeled outer package may not reflect the size of the product contained in the package | 275 units | 2014-03-04 |
| Coopersurgical, Inc. | 510(k) number | 2013-02-26 | Class III | Packaging process control | Pessary mislabeled outer package may not reflect the size of the product contained in the package | 175 units | 2014-03-04 |
| Coopersurgical, Inc. | 510(k) number | 2013-02-26 | Class III | Packaging process control | Pessary mislabeled outer package may not reflect the size of the product contained in the package | 70 units | 2014-03-04 |
| Coopersurgical, Inc. | 510(k) number | 2013-02-26 | Class III | Packaging process control | Pessary mislabeled outer package may not reflect the size of the product contained in the package | 20 units | 2014-03-04 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2021-01-21 | Class II | Process change control | The affected Milex Gellhorn pessaries were incorrectly manufactured with a long stem (2.170 ), instead of a short stem (1.670 or 1.960 nominal height) as required. The length discrepancy does not meet the released print dimensions. | 109 units (Domestic: 60 units, Foreign: 49 units) | 2024-01-03 |
| 2015-09-14 | Class III | Labeling mix-ups | The products have been identified to have incorrect size prints on the MILEX PESSARY KIT packaging. While the Pessary pouch is marked with correct size, an incorrect label on the packaging does not meet the required release specification. | 144 units | 2016-01-08 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.