FDA Product Code
FDA Product Code HFX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.4530
510(k) Clearances — 27 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K251687 | Konig Bell Circumcision Clamp | Medline Industries, LP | 2026-02-25 | Traditional | PDF ↗ |
| K221356 | Wee Bell | Wee Medical | 2023-02-02 | Traditional | PDF ↗ |
| K212911 | Konig Mogen Clamp | Medline Industries, Inc. | 2022-11-18 | Traditional | PDF ↗ |
| K151095 | Circumplast Circumcision Device | Novadien Healthcare | 2015-09-18 | Traditional | PDF ↗ |
| K142163 | MALE CIRCUMCISION KITS:RAPIDECLAMP | Medicfit Technology Sdn Bhd | 2015-04-20 | Traditional | PDF ↗ |
| K131373 | SHANGRING | Wuhu Snnda Medical Treatment Appliance Technology | 2013-06-25 | Special | PDF ↗ |
| K121789 | SHANGRING | Wuhu Snna Medical Treatment Appliance Technology C | 2012-08-03 | Traditional | PDF ↗ |
| K103695 | PREPEX SYSTEM | Circ Medtech | 2012-01-10 | Traditional | PDF ↗ |
| K100916 | MEDICON MOGEN CLAMP | Medicon EG | 2010-12-06 | Traditional | PDF ↗ |
| K061539 | GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE | Clinical Innovations, LLC | 2007-09-20 | Traditional | PDF ↗ |
| K063429 | GMD UNIVERSAL CIRCUMCISION CLAMP, MODEL 200 | Generic Medical Device, Inc. | 2007-01-17 | Traditional | PDF ↗ |
| K043533 | SURGICAL DESIGN CIRCUMCISION CLAMP | Surgical Design, Inc. | 2005-04-01 | Traditional | PDF ↗ |
| K040052 | FINE SURGICAL CIRCUMCISION CLAMP | Fine Surgical Instrument Corp. | 2004-04-09 | Traditional | PDF ↗ |
| K032091 | SMART KLAMP VARIOUS BY SIZE | Emergogroup, Inc. | 2004-03-08 | Traditional | PDF ↗ |
| K033403 | T.S. MEDICAL CIRCUMCISION CLAMP | T.S. Medical | 2004-01-22 | Traditional | PDF ↗ |
| K010867 | KILEJIAN CIRCUMCISOR | Iris Surgical, LLC | 2001-05-03 | Traditional | PDF ↗ |
| K974286 | CIRCUMCISION TRAY, CAT. NO. 70340 | Trinity Laboratories, Inc. | 1997-12-12 | Traditional | PDF ↗ |
| K970282 | MEDLINE CIRCUMCISION TRAY | Medline | 1997-03-06 | Traditional | PDF ↗ |
| K945949 | KILEJIAN CIRCUMCISION TEMPLATE [THE DOME] | Vlm Surgical, Inc. | 1995-07-25 | Traditional | PDF ↗ |
| K935697 | CIRCUMCISION TRAY | Cush Medical Products | 1994-05-02 | Traditional | PDF ↗ |
| K926535 | GOMCO CIRCUMCISION CLAMP | Thomasville Medical Assoc. | 1994-02-25 | Traditional | PDF ↗ |
| K926471 | MOGAN CIRCUMCISION CLAMP | Thomasville Medical Assoc. | 1994-02-25 | Traditional | PDF ↗ |
| K935491 | CENTURION MOGEN CLAMP/CIRCUMCISION (STER/NON STER) | Tri-State Hospital Supply Corp. | 1994-02-17 | Traditional | PDF ↗ |
| K900370 | ONE/CIRC (CIRCUMCISION CLAMP) | Bionix Development Corp. | 1990-04-16 | Traditional | PDF ↗ |
| K894201 | GOMCO CIRCUMCISION CLAMP | Zinnanti Surgical Instruments, Inc. | 1989-08-11 | Traditional | PDF ↗ |
| K890897 | CENTURION CIRCLAMP | Tri-State Hospital Supply Corp. | 1989-03-28 | Traditional | PDF ↗ |
| K884290 | BAXTER DISPOSABLE CIRCUMCISION TRAY | Baxter Healthcare Corp | 1988-12-08 | Traditional | PDF ↗ |
Product code HFX · Class II · Obstetrics/Gynecology. Data: openFDA.