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Disposable Endoscopic Linear Cutter Staplers and Reloads
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Disposable Endoscopic Linear Cutter Staplers and Reloads FDA UDI
- Generic Name
- Endoscopic manual linear cutting stapler, single-use FDA UDI
- Model / Reference
- DEC-B 60 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06946480589311 FDA UDI
- 510(k) Number
- K131511 FDA UDI
- FDA Product Code
- GDW 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 UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Endoscopic manual linear cutting stapler, single-use
Disposable Endoscopic Linear Cutter Staplers and Reloads by Sinolinks Medical Innovation Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID
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
- Titan SGS Standard Gastric Stapler — Standard Bariatrics · 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
Cleared under the same submission
K131511 also covers:
- Disposable Circular Staplers — Sinolinks Medical Innovation Co., Ltd.
- Disposable Linear Cutter Staplers and Reloads — Sinolinks Medical Innovation Co., Ltd.
- Disposable Linear Cutter Staplers and Reloads — Sinolinks Medical Innovation Co., Ltd.
- Disposable Linear Staplers and Reloads — Sinolinks Medical Innovation Co., Ltd.
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
- Sinolinks Medical Innovation Co., Ltd.
Sources (1)
- FDA UDI d56f96ff-a192-4ded-9b7d-535a150ff4eb 33 fields · synced May 30, 2026