Centurion
18 catalogue numbers from 200CR, listed by Centurion Medical Products Corporation, United States, under Clamp, Circumcision. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
18catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (1), Anhui (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Wuhu Snnda Medical Treatment Appliance Technology Co., Ltd. | Wuhu | Anhui | Manufacturer | 1 |
Record
| Listed by | Centurion Medical Products Corporation, United States |
|---|---|
| FDA product code | HFX |
| Device type | Clamp, Circumcision |
| Device class | Class 2 |
| Regulation | 21 CFR 884.4530 |
| 510(k) | K890897 |
| Record published | 2016-08-31 |
| Record revised | 2020-05-04 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 12, case of 48 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 200CR | In distribution | |
| CR210K | In distribution | |
| 245CR | In distribution | |
| GCPP310 | In distribution | |
| 310CRK | In distribution | |
| CR230K | In distribution | |
| CR345K | In distribution | |
| 3145CRSK | In distribution | |
| 210CR | In distribution | |
| 310CR | In distribution | |
| CR3145K | In distribution | |
| 345CR | In distribution | |
| 230CR | In distribution | |
| 330CRK | In distribution | |
| CR245K | In distribution | |
| 330CR | In distribution | |
| 3145CR | In distribution | |
| GCPP330 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ShangRing | Wuhu Snnda Medical Treatment Appliance Technology Co., Ltd. | 24 |
| Devon | Cardinal Health | 17 |
| Gomco Circumcision Clamp | Sontec Instruments, Inc. | 16 |
| Gomco | Allied Medical LLC | 9 |
| Circumplast | Emboss Medical Limited | 8 |
| Aesculap | Aesculap AG | 6 |
| Medical Action Industries | Medical Action Industries, Inc. | 4 |
| AccuCirc® | Clinical Innovations, LLC | 4 |
| Gomco Type Circumcision Clamp | Fine Surgical Instruments Inc. | 4 |
| Medline | Medline Industries, Inc. | 3 |
| Mogen Circumcision Clamp | Sontec Instruments, Inc. | 2 |
| Gomco Circumcision Clamp Chrome | Sontec Instruments, Inc. | 2 |
Showing 12 of 21. All products under Clamp, Circumcision
Recalls Naming This Product
7 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 |
|---|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | 510(k) number | 2024-09-03 | Class II | Device Design | Product has been identified as having holes in the packaging. | 498,354 kits | |
| Medline Industries, LP – Northfield | 510(k) number | 2023-05-23 | Class II | Process control | The kits incorrectly contain CirClamp subassembly 345CRSAK which results in the kits containing an incorrect bell and base size. | 106 units | |
| Medline Industries, LP – Northfield | 510(k) number | 2023-03-02 | Class II | Under Investigation by firm | The CirClamp subassembly found in the kit was the incorrect size. | 162 units | |
| Centurion Medical Products, LP | 510(k) number | 2019-08-28 | Class II | Process control | A mismatch between the angle of the hole in the base and the angle of the bell, which may cause the clamp to remove foreskin without the use of a scalpel. | 1530 each | 2020-07-23 |
| Centurion Medical Products, LP | 510(k) number | 2019-08-28 | Class II | Process control | A mismatch between the angle of the hole in the base and the angle of the bell, which may cause the clamp to remove foreskin without the use of a scalpel. | 204 each | 2020-07-23 |
| Centurion Medical Products, LP | 510(k) number | 2005-04-12 | Not classified | Other | Lot 11224 may contain a 1.1 cm clamp and bell and neither lot is labeled as reprocessed, when they have been reprocessed. | 4078 | 2005-09-08 |
| Centurion Medical Products, LP | 510(k) number | 2005-04-12 | Not classified | Other | Not labeled as reprocessed, when this lot has been reprocessed. | 1572 | 2005-09-08 |
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.