Clamp, Circumcision
FDA product code HFX · Class II (moderate risk) · 21 CFR 884.4530 · Obstetrics/Gynecology
27510(k) clearances
0PMA approvals
12recalls
Manufacturers
- Tri-State Hospital Supply Corporation 2
- Medline Industries, LP 2
- Thomasville Medical Assoc. 2
- Fine Surgical Instrument Corp. 1
- Baxter Healthcare Corp 1
- Wee Medical 1
- Wuhu Snna Medical Treatment Appliance Technology C 1
- Circ Medtech 1
- Medicon EG 1
- Clinical Innovations, LLC 1
- Generic Medical Device, Inc. 1
- Surgical Design Corp. 1
- Bionix Development Corp. 1
- Emergogroup, Inc. 1
- T.S. Medical 1
- Iris Surgical, LLC 1
- Trinity Laboratories, Inc. 1
- Medline 1
- Vlm Surgical, Inc. 1
- Cush Medical Products 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251687 | Konig Bell Circumcision ClampHFX · Traditional | Medline Industries, LP | 02/25/2026SE |
| K221356 | Wee BellHFX · Traditional | Wee Medical | 02/02/2023SE |
| K212911 | Konig Mogen ClampHFX · Traditional | Medline Industries, Inc. | 11/18/2022SE |
| K151095 | Circumplast Circumcision DeviceHFX · Traditional | Novadien Healthcare | 09/18/2015SE |
| K142163 | Male Circumcision Kits:RapideclampHFX · Traditional | Medicfit Technology Sdn Bhd | 04/20/2015SE |
| K131373 | ShangringHFX · Special | Wuhu Snnda Medical Treatment Appliance Technology | 06/25/2013SE |
| K121789 | ShangringHFX · Traditional | Wuhu Snna Medical Treatment Appliance Technology C | 08/03/2012SE |
| K103695 | Prepex SystemHFX · Traditional | Circ Medtech | 01/10/2012SE |
| K100916 | Medicon Mogen ClampHFX · Traditional | Medicon EG | 12/06/2010SE |
| K061539 | Gomco Circumcision Clamp, Mogen Clamp, Plastibell Circumcision DeviceHFX · Traditional | Clinical Innovations, LLC | 09/20/2007SE |
| K063429 | GMD Universal Circumcision Clamp, Model 200HFX · Traditional | Generic Medical Device, Inc. | 01/17/2007SE |
| K043533 | Surgical Design Circumcision ClampHFX · Traditional | Surgical Design, Inc. | 04/01/2005SE |
| K040052 | Fine Surgical Circumcision ClampHFX · Traditional | Fine Surgical Instrument Corp. | 04/09/2004SE |
| K032091 | Smart Klamp Various by SizeHFX · Traditional | Emergogroup, Inc. | 03/08/2004SE |
| K033403 | T.S. Medical Circumcision ClampHFX · Traditional | T.S. Medical | 01/22/2004SE |
| K010867 | Kilejian CircumcisorHFX · Traditional | Iris Surgical, LLC | 05/03/2001SE |
| K974286 | Circumcision Tray, Cat. No. 70340HFX · Traditional | Trinity Laboratories, Inc. | 12/12/1997SE |
| K970282 | Medline Circumcision TrayHFX · Traditional | Medline | 03/06/1997SE |
| K945949 | Kilejian Circumcision Template [The Dome]HFX · Traditional | Vlm Surgical, Inc. | 07/25/1995SE |
| K935697 | Circumcision TrayHFX · Traditional | Cush Medical Products | 05/02/1994SEKD |
| K926535 | Gomco Circumcision ClampHFX · Traditional | Thomasville Medical Assoc. | 02/25/1994SE |
| K926471 | Mogan Circumcision ClampHFX · Traditional | Thomasville Medical Assoc. | 02/25/1994SE |
| K935491 | Centurion Mogen Clamp/Circumcision (Ster/Non Ster)HFX · Traditional | Tri-State Hospital Supply Corp. | 02/17/1994SE |
| K900370 | One/Circ (Circumcision Clamp)HFX · Traditional | Bionix Development Corp. | 04/16/1990SE |
| K894201 | Gomco Circumcision ClampHFX · Traditional | Zinnanti Surgical Instruments, Inc. | 08/11/1989SE |
| K890897 | Centurion CirclampHFX · Traditional | Tri-State Hospital Supply Corp. | 03/28/1989SE |
| K884290 | Baxter Disposable Circumcision TrayHFX · Traditional | Baxter Healthcare Corp | 12/08/1988SESD |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0133-2025 Class II | (1) Centurion Sterile CirClamp, Reorder #200CR; (2) Centurion CirClamp with 1.1cm Bell…Product has been identified as having holes in the packaging. | MEDLINE INDUSTRIES, LP - Northfield | 09/03/2024Open, Classified |
| Z-2649-2023 Class II | Centurion Sterile CirClamp with 1.45cm Bell Reprocessed, Reorder CR3145K, 1 per package…The kits incorrectly contain CirClamp subassembly 345CRSAK which results in the kits containing an incorrect… | MEDLINE INDUSTRIES, LP - Northfield | 05/23/2023Open, Classified |
| Z-1407-2023 Class II | Centurion CirClamp with 1.3cm Bell & Insert Reprocessed, Reorder #CR230K, Sterile.The CirClamp subassembly found in the kit was the incorrect size. | MEDLINE INDUSTRIES, LP - Northfield | 03/02/2023Open, Classified |
| Z-0121-2020 Class II | Centurion CIRCLAMP W/1.3 CM BELL-single-use, disposable instrument used to compress the…A mismatch between the angle of the hole in the base and the angle of the bell, which may cause the clamp to… | Centurion Medical Products Corporation | 08/28/2019Terminated |
| Z-0120-2020 Class II | Centurion CIRCLAMP W/1.1CM BELL - single-use, disposable instrument used to compress the…A mismatch between the angle of the hole in the base and the angle of the bell, which may cause the clamp to… | Centurion Medical Products Corporation | 08/28/2019Terminated |
| Z-0947-2017 Class II | Gomco Circumcision Clamps with separate O-Ring Component: The device is packaged…Aesculap has received complaints of excessive bleeding after use of Gomco Circumcision Clamps. | Aesculap Implant Systems LLC | 10/28/2016Terminated |
| Z-0538-2015 Class II | A circumcision clamp is an instrument used to compress the foreskin of the penis during…The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market… | Instrumed International, Inc. | 09/08/2014Terminated |
| Z-0534-2015 Class II | A zipser clamp is an instrument used to compress reduce blood flow to the penis and…The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market… | Instrumed International, Inc. | 09/08/2014Terminated |
| Z-1134-2014 Class II | DeRoyal ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack, Rx Only STERILE…Three lots of circumcision clamps were manufactured out of specification and as a result may not properly… | DeRoyal Industries Inc | 01/16/2014Terminated |
| Z-3254-2011 | Circumcision trays and packs listed as follows: (1) DeRoyal (R) ST. Circumcision Tray…The firm distributed surgical kits which contained circumcision clamps that were subsequently recalled by… | Deroyal Industries, Inc. Lafollette | 05/05/2011Terminated |
| Z-3253-2011 | DeRoyal (R) ST. Circumcision Clamp, REF 32-1622, 1 Per Pack, Rx Only STERILE EO…The firm distributed surgical kits which contained circumcision clamps that were subsequently recalled by… | Deroyal Industries, Inc. Lafollette | 05/05/2011Terminated |
| Z-2153-2011 | Circumcision Clamp, models 1.1 cm and 1.3 cm, Circumcision clamp is an instrument used…Medical device used in surgical procedure is defective and may break during use. | Surgical Design Inc | 01/26/2011Terminated |