Identity
- Trade Name
- SGIA FDA UDI
- Generic Name
- Open-surgery manual linear stapler, single-use FDA UDI
- Device Name
- Knifeless Stapler with DST Series Technology FDA UDI
- Model / Reference
- SGIA6038S FDA UDI
- Description
- Knifeless Stapler with DST Series Technology FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884523007299 FDA UDI
- 510(k) Number
- K111825 FDA UDI
- FDA Product Code
- GDW FDA UDI
- GMDN Term
- Open-surgery manual linear 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
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
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 60 Millimeter FDA UDIHeight — 3.8 Millimeter FDA UDI
Category: Open-surgery manual linear stapler, single-use
Sgia by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Open-surgery manual linear stapler, single-use.
- Single Use Linear Staplers — Victor Medical Instruments Co., Ltd. · Class IIb
- Single Use Linear Staplers — Victor Medical Instruments Co., Ltd. · Class IIb
- Linear Stapler — B. J. ZH. F. Panther Medical Equipment Co., Ltd. · Class II
- Linear Stapler — B. J. ZH. F. Panther Medical Equipment Co., Ltd. · Class II
- ETHICON SECURESTRAP — Ethicon Inc. · Class II
- Linear Stapler — B. J. ZH. F. Panther Medical Equipment Co., Ltd. · Class II
- PROXIMATE — Ethicon Endo-Surgery, LLC · Class IIb
- PROXIMATE — Ethicon Endo-Surgery, LLC · Class IIb
Cleared under the same submission
K111825 also covers:
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
- Covidien LP
Sources (1)
- FDA UDI 41129993-1fbd-4d43-ad1e-c12fc10cb264 37 fields · synced May 31, 2026