Identity
- Trade Name
- TITAN Standard Power Unit FDA UDI
- Generic Name
- Endoscopic manual linear cutting stapler, single-use FDA UDI
- Model / Reference
- SPU01 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851677007096 FDA UDI
- 510(k) Number
- K210278 FDA UDI
- FDA Product Code
- GDW FDA UDIGAG FDA UDI
- GMDN Term
- Endoscopic manual linear cutting stapler, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4750 FDA UDI878.4740 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Endoscopic manual linear cutting stapler, single-use
TITAN Standard Power Unit by Standard Bariatrics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic manual linear cutting stapler, single-use.
- ECHELON ENDOPATH — ETHICON ENDO-SURGERY, INC. · Class II
- Endo GIA Ultra — Covidien LP · Class II
- easyLCTM Linear Cutter Staplers and Loading Units for Single Use — Ezisurg Medical Co., Ltd. · Class II
- easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use — Ezisurg Medical Co., Ltd. · Class II
- Reloading Unit for Endo Linear Cutter Stapler — B. J. ZH. F. Panther Medical Equipment Co., Ltd. · Class II
- Reloading Unit for Endo Linear Cutter Stapler — B. J. ZH. F. Panther Medical Equipment Co., Ltd. · Class II
- ENDOPATH — ETHICON ENDO-SURGERY, INC. · Class II
- Reloading Unit for Endo Linear Cutter Stapler — B. J. ZH. F. Panther Medical Equipment Co., Ltd. · Class II
Cleared under the same submission
K210278 also covers:
- Titan SGS Bailout Chuck — Standard Bariatrics
- Titan SGS Standard Gastric Stapler — Standard Bariatrics
- Titan SGS Standard Gastric Stapler — Standard Bariatrics
- Titan SGS Standard Gastric Stapler — Standard Bariatrics
- TELEFLEX — TELEFLEX INCORPORATED
- TELEFLEX — TELEFLEX INCORPORATED
- TELEFLEX — TELEFLEX INCORPORATED
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
- Standard Bariatrics
Sources (1)
- FDA UDI ec715e27-f593-4221-badb-d0088f06c849 33 fields · synced Jun 8, 2026