Identity
- Trade Name
- GOMCO CIRCUMCISION CLAMP FDA UDI
- Generic Name
- Surgical penis clamp, reusable FDA UDI
- Device Name
- GOMCO CIRCUMCISION CLAMP CHROME FDA UDI
- Model / Reference
- 540-394 FDA UDI
- Description
- GOMCO CIRCUMCISION CLAMP CHROME FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00192896001626 FDA UDI
- 510(k) Number
- K040052 FDA UDI
- FDA Product Code
- HFX FDA UDI
- GMDN Term
- Surgical penis clamp, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.4530 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 14.5 Millimeter FDA UDI
Category: Surgical penis clamp, reusable
Gomco Circumcision Clamp by Sontec Instruments, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical penis clamp, reusable.
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Cleared under the same submission
K040052 also covers:
- Devon — Cardinalhealth
- Devon — Cardinalhealth
- Devon — Cardinalhealth
- Devon — Cardinalhealth
- Devon — Cardinalhealth
- Devon — Cardinalhealth
- Devon — Cardinalhealth
- Devon — Cardinalhealth
- Devon — Cardinalhealth
- Devon — Cardinalhealth
- Gomco Type Circumcision Clamp — FINE SURGICAL INSTRUMENTS INC.
- Gomco Type Circumcision Clamp — FINE SURGICAL INSTRUMENTS INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sontec Instruments, Inc.
Sources (1)
- FDA UDI 8bb0ef5c-4077-48d2-9282-9e7075dfd151 36 fields · synced May 30, 2026