Identity
- Trade Name
- Fastclamp FDA UDI
- Generic Name
- Medical table clamp FDA UDI
- Device Name
- FASTCLAMP SYSTEM Table Clamp Medical Table Clamp FDA UDI
- Model / Reference
- TC-1000-02 FDA UDI
- Description
- FASTCLAMP SYSTEM Table Clamp Medical Table Clamp FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051986006581 FDA UDI
- 510(k) Number
- K100442 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Medical table clamp FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
No
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Medical table clamp
Fastclamp by Surgical Innovations Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Medical table clamp.
- Dual Pendant Holder — Mizuho Orthopedic Systems, Inc. · Class I
- Quad® Clamp — INNOVATIVE MEDICAL PRODUCTS, INC. · Class I
- Side rail adapter pair — Maquet, Inc. · Class I
- SPRINGLOC CLAMP JPN — Skytron, LLC · Class I
- De Mayo Push Button™ Clamp — INNOVATIVE MEDICAL PRODUCTS, INC. · Class I
- Radial clamp — Reison Medical AB · Class I
- Secure-Release — STERIS CORPORATION · Class I
- COUPLER II RADIOLUCENT DORO ADAPTER, REFURBISHED — Mizuho Orthopedic Systems, Inc. · Class I
Cleared under the same submission
K100442 also covers:
- Snowden-Pencer — STERIS CORPORATION
- Snowden-Pencer — STERIS CORPORATION
- Snowden-Pencer — STERIS CORPORATION
- Snowden-Pencer — STERIS CORPORATION
- Snowden-Pencer — STERIS CORPORATION
- Fastclamp — SURGICAL INNOVATIONS LIMITED
- Fastclamp — SURGICAL INNOVATIONS LIMITED
- Fastclamp — SURGICAL INNOVATIONS LIMITED
- Fastclamp — SURGICAL INNOVATIONS LIMITED
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 |
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Manufacturer
- Manufacturer
- Surgical Innovations Limited
Sources (1)
- FDA UDI 4f60964b-ce5a-4a55-95ef-23e0f8c82583 34 fields · synced Jun 8, 2026