Identity
- Trade Name
- TELEFLEX FDA UDI
- Generic Name
- Endoscopic motorized cutting stapler, single-use FDA UDI
- Device Name
- TITAN SGS STANDARD POWER UNIT FDA UDI
- Model / Reference
- IPN928804 FDA UDI
- Description
- TITAN SGS STANDARD POWER UNIT FDA UDI
Identifiers
- Catalog Number
- SPU01 FDA UDI
- Primary DI / UDI-DI
- 14026704921772 FDA UDI
- 510(k) Number
- K210278 FDA UDI
- FDA Product Code
- GDW FDA UDI
- GMDN Term
- Endoscopic motorized cutting stapler, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4750 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Endoscopic motorized cutting stapler, single-use
Teleflex by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Endoscopic motorized cutting stapler, single-use.
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- ECHELON Flex ENDOPATH — ETHICON ENDO-SURGERY, INC. · Class II
- ECHELON FLEX — ETHICON ENDO-SURGERY, INC. · Class II
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- ETHICON — ETHICON ENDO-SURGERY, INC. · Class II
Cleared under the same submission
K210278 also covers:
- TITAN Standard Power Unit — Standard Bariatrics
- 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
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
- Teleflex Incorporated
Sources (1)
- FDA UDI 4b4eea21-6396-49b0-8f85-a6e5a068bcab 36 fields · synced May 30, 2026