Apogee
Intermittent Catheter, 14 Fr 16 in, Soft, Curved Package, Straight
11manufacturers in China registered for this device type
23catalogue numbers in this listing
11510(k) clearances naming this product code
Who Else Makes It
Concentrated in Zhejiang (6), Jiangsu (4), Guangdong (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Jingle Polymer Medical Apparatus Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Integral Medical Products Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 7 |
| Xianju Bever Medical Devices Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 3 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Nanjing Anjian Medical Device Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 22 |
| Suzhou Prosteri Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Hangzhou Jimushi Meditech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Integral Sterilization Technology (Shaoxing) Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 5 |
| Hangzhou Bever Medical Devices Co., Ltd. | Hangzhou | Zhejiang | Specification developer | 3 |
| Xianju JF Medister Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 2 |
Record
| Listed by | Hollister Incorporated, United States |
|---|---|
| FDA product code | GBM |
| Device type | Catheter, Urethral |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5130 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K992137 |
| Record published | 2016-09-21 |
| Record revised | 2025-06-03 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 18, case of 15, case of 6 |
| Sizes | Length 6 to 16 in; catheter gauge 6 to 18 Fr |
| Distribution end date | 2025-05-30 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| B1061 | Length 16 in | 30 | In distribution |
| 10616Q | Catheter Gauge 6 Fr | 30 | In distribution |
| 11216Q | Length 16 in | 30 | In distribution |
| 11026Q | Length 16 in | 30 | In distribution |
| 11426Q | Catheter Gauge 14 Fr | 30 | In distribution |
| 10806Q | Catheter Gauge 8 Fr | 30 | In distribution |
| 11206Q | Catheter Gauge 12 Fr | 30 | In distribution |
| 11016Q | Length 16 in | 30 | In distribution |
| 11006Q | Length 6 in | 30 | In distribution |
| B1065 | Catheter Gauge 14 Fr | 50 | In distribution |
| 11616Q | Catheter Gauge 16 Fr | 30 | In distribution |
| 10816Q | Length 16 in | 30 | In distribution |
| 11626Q | Length 16 in | 30 | In distribution |
| 11826Q | Length 16 in | 30 | In distribution |
| B1074A | Catheter Gauge 14 Fr | 50 | Withdrawn |
| B1049 | Length 16 in | 50 | Withdrawn |
| 1084 | Length 16 in | 30 | Withdrawn |
| 1036 | Catheter Gauge 10 Fr | 30 | Withdrawn |
| 1051 | Catheter Gauge 12 Fr | 30 | Withdrawn |
| B1087 | Catheter Gauge 14 Fr | 50 | Withdrawn |
| 1083 | Catheter Gauge 16 Fr | 30 | Withdrawn |
| 1067 | Length 16 in | 30 | Withdrawn |
| B1046 | Catheter Gauge 12 Fr | 30 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| BeneCath® | Hangzhou Jimushi Meditech Co., Ltd. | 57 |
| SpeediCath Standard | Coloplast A/S | 47 |
| TruCath | HR Pharmaceuticals Inc. | 46 |
| VaPro | Hollister Incorporated | 31 |
| Actreen® | B. Braun Medical Inc. | 28 |
| McKesson | Mckesson Medical-Surgical Inc. | 25 |
| BD Intermittent | Hangzhou Bever Medical Devices Co., Ltd. | 24 |
| Gentlecath AIR | Convatec, Purchasing Department | 24 |
| VaPro Pocket | Hollister Incorporated | 23 |
| Dover | Cardinal Health | 23 |
| Dover | Cardinal Health 200, LLC | 22 |
| Teleflex | Teleflex Medical LLC | 22 |
Showing 12 of 76. All products under Catheter, Urethral
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K211436 | 2022-01-27 |
| K193148 | 2019-12-13 |
| K191633 | 2019-07-19 |
| K183253 | 2018-12-18 |
| K180824 | 2018-06-22 |
| K163179 | 2017-01-26 |
| K152268 | 2015-09-09 |
| K143594 | 2015-01-09 |
| K141642 | 2014-08-22 |
| K110862 | 2011-04-26 |
| K090960 | 2009-08-20 |
Recalls Naming This Product
5 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 |
|---|---|---|---|---|---|---|---|
| Robling Medical, LLC | 510(k) number | 2008-07-17 | Not classified | Packaging process control | Due to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to the urethra upon use. Also the sterility of the product could be compromised. | 2700 pcs | 2009-06-04 |
| Robling Medical, LLC | 510(k) number | 2008-07-17 | Not classified | Packaging process control | Due to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to the urethra upon use. Also the sterility of the product could be compromised. | 5400 pcs | 2009-06-04 |
| Robling Medical, LLC | 510(k) number | 2008-07-17 | Not classified | Packaging process control | Due to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to the urethra upon use. Also the sterility of the product could be compromised. | 5940 pcs | 2009-06-04 |
| Robling Medical, LLC | 510(k) number | 2008-07-17 | Not classified | Packaging process control | Due to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to the urethra upon use. Also the sterility of the product could be compromised. | 2700 pcs | 2009-06-04 |
| Robling Medical, LLC | 510(k) number | 2008-07-17 | Not classified | Packaging process control | Due to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to the urethra upon use. Also the sterility of the product could be compromised. | 7560 pcs | 2009-06-04 |
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.