Circumplast Circumcision Device
FDA 510(k) clearance K151095 · decided 2015-09-18
Clearance details
- K-number
- K151095
- Device name
- Circumplast Circumcision Device
- Applicant
- Novadien Healthcare
- Decision
- Substantially Equivalent
- Date received
- 2015-04-23
- Decision date
- 2015-09-18
- Days to decision
- 148 days
- Clearance type
- Traditional
- Product code
- HFX
- Device class
- 2
- Regulation number
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Mount Lewis, AU
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Konig Bell Circumcision Clamp (K251687) | Medline Industries, LP | 2026-02-25 |
| Wee Bell (K221356) | Wee Medical | 2023-02-02 |
| Konig Mogen Clamp (K212911) | Medline Industries, Inc. | 2022-11-18 |
| MALE CIRCUMCISION KITS:RAPIDECLAMP (K142163) | Medicfit Technology Sdn Bhd | 2015-04-20 |
| SHANGRING (K131373) | Wuhu Snnda Medical Treatment Appliance Technology | 2013-06-25 |
| SHANGRING (K121789) | Wuhu Snna Medical Treatment Appliance Technology C | 2012-08-03 |
| PREPEX SYSTEM (K103695) | Circ Medtech | 2012-01-10 |
| MEDICON MOGEN CLAMP (K100916) | Medicon EG | 2010-12-06 |
| GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE (K061539) | Clinical Innovations, LLC | 2007-09-20 |
| GMD UNIVERSAL CIRCUMCISION CLAMP, MODEL 200 (K063429) | Generic Medical Device, Inc. | 2007-01-17 |
| SURGICAL DESIGN CIRCUMCISION CLAMP (K043533) | Surgical Design, Inc. | 2005-04-01 |
| FINE SURGICAL CIRCUMCISION CLAMP (K040052) | Fine Surgical Instrument Corp. | 2004-04-09 |
Recalls involving this device
No recalls on record reference this clearance.