Product code HFX
- Device name
- Clamp, Circumcision
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.4530
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251687 | Konig Bell Circumcision Clamp | Medline Industries, LP | 2026-02-25 |
| K221356 | Wee Bell | Wee Medical | 2023-02-02 |
| K212911 | Konig Mogen Clamp | Medline Industries, Inc. | 2022-11-18 |
| K151095 | Circumplast Circumcision Device | Novadien Healthcare | 2015-09-18 |
| K142163 | MALE CIRCUMCISION KITS:RAPIDECLAMP | Medicfit Technology Sdn Bhd | 2015-04-20 |
| K131373 | SHANGRING | Wuhu Snnda Medical Treatment Appliance Technology | 2013-06-25 |
| K121789 | SHANGRING | Wuhu Snna Medical Treatment Appliance Technology C | 2012-08-03 |
| K103695 | PREPEX SYSTEM | Circ Medtech | 2012-01-10 |
| K100916 | MEDICON MOGEN CLAMP | Medicon EG | 2010-12-06 |
| K061539 | GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE | Clinical Innovations, LLC | 2007-09-20 |
| K063429 | GMD UNIVERSAL CIRCUMCISION CLAMP, MODEL 200 | Generic Medical Device, Inc. | 2007-01-17 |
| K043533 | SURGICAL DESIGN CIRCUMCISION CLAMP | Surgical Design, Inc. | 2005-04-01 |
| K040052 | FINE SURGICAL CIRCUMCISION CLAMP | Fine Surgical Instrument Corp. | 2004-04-09 |
| K032091 | SMART KLAMP VARIOUS BY SIZE | Emergogroup, Inc. | 2004-03-08 |
| K033403 | T.S. MEDICAL CIRCUMCISION CLAMP | T.S. Medical | 2004-01-22 |
| K010867 | KILEJIAN CIRCUMCISOR | Iris Surgical, LLC | 2001-05-03 |
| K974286 | CIRCUMCISION TRAY, CAT. NO. 70340 | Trinity Laboratories, Inc. | 1997-12-12 |
| K970282 | MEDLINE CIRCUMCISION TRAY | Medline | 1997-03-06 |
| K945949 | KILEJIAN CIRCUMCISION TEMPLATE [THE DOME] | Vlm Surgical, Inc. | 1995-07-25 |
| K935697 | CIRCUMCISION TRAY | Cush Medical Products | 1994-05-02 |
| K926471 | MOGAN CIRCUMCISION CLAMP | Thomasville Medical Assoc. | 1994-02-25 |
| K926535 | GOMCO CIRCUMCISION CLAMP | Thomasville Medical Assoc. | 1994-02-25 |
| K935491 | CENTURION MOGEN CLAMP/CIRCUMCISION (STER/NON STER) | Tri-State Hospital Supply Corp. | 1994-02-17 |
| K900370 | ONE/CIRC (CIRCUMCISION CLAMP) | Bionix Development Corp. | 1990-04-16 |
| K894201 | GOMCO CIRCUMCISION CLAMP | Zinnanti Surgical Instruments, Inc. | 1989-08-11 |
| K890897 | CENTURION CIRCLAMP | Tri-State Hospital Supply Corp. | 1989-03-28 |
| K884290 | BAXTER DISPOSABLE CIRCUMCISION TRAY | Baxter Healthcare Corp | 1988-12-08 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10197344003075 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2026-01-12 |
| 16939550822309 | ShangRing | Wuhu Snnda Medical Treatment Appliance Technology Co., Ltd. | 2021-03-19 |
| 16939550822293 | ShangRing | Wuhu Snnda Medical Treatment Appliance Technology Co., Ltd. | 2021-03-19 |
| 16939550822286 | ShangRing | Wuhu Snnda Medical Treatment Appliance Technology Co., Ltd. | 2021-03-19 |
| 16939550822262 | ShangRing | Wuhu Snnda Medical Treatment Appliance Technology Co., Ltd. | 2021-03-19 |
| 16939550822248 | ShangRing | Wuhu Snnda Medical Treatment Appliance Technology Co., Ltd. | 2021-03-19 |
| 16939550822224 | ShangRing | Wuhu Snnda Medical Treatment Appliance Technology Co., Ltd. | 2021-03-19 |
| 16939550822200 | ShangRing | Wuhu Snnda Medical Treatment Appliance Technology Co., Ltd. | 2021-03-19 |
| 16939550822187 | ShangRing | Wuhu Snnda Medical Treatment Appliance Technology Co., Ltd. | 2021-03-19 |
| 16939550822163 | ShangRing | Wuhu Snnda Medical Treatment Appliance Technology Co., Ltd. | 2021-03-19 |
| 16939550822156 | ShangRing | Wuhu Snnda Medical Treatment Appliance Technology Co., Ltd. | 2021-03-19 |
| 16939550822149 | ShangRing | Wuhu Snnda Medical Treatment Appliance Technology Co., Ltd. | 2021-03-19 |
| 16939550822132 | ShangRing | Wuhu Snnda Medical Treatment Appliance Technology Co., Ltd. | 2021-03-19 |
| 16939550822125 | ShangRing | Wuhu Snnda Medical Treatment Appliance Technology Co., Ltd. | 2021-03-19 |
| 16939550822118 | ShangRing | Wuhu Snnda Medical Treatment Appliance Technology Co., Ltd. | 2021-03-19 |
| 10653160312956 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2017-10-14 |
| 10653160312949 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2017-10-14 |
| 10653160312932 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2017-10-14 |
| 10653160312901 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2017-10-14 |
| 10653160312895 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2017-10-14 |
| 10653160309901 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2017-05-25 |
| 10653160309895 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2017-05-25 |
| 10649111043192 | Sklar® | SKLAR CORPORATION | 2017-03-04 |
| 10080196301904 | Medline | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 10885403108341 | N/A | CAREFUSION 2200, INC | 2016-09-30 |
| 10653160278139 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2016-08-31 |
| 10809160023648 | Medical Action Industries | MEDICAL ACTION INDUSTRIES INC. | 2016-08-20 |
| 10809160023631 | Medical Action Industries | MEDICAL ACTION INDUSTRIES INC. | 2016-08-20 |
| 10809160023624 | Medical Action Industries | MEDICAL ACTION INDUSTRIES INC. | 2016-08-20 |
| 10809160023617 | Medical Action Industries | MEDICAL ACTION INDUSTRIES INC. | 2016-08-20 |