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Endo GIA

FDA UDI

Class II (US FDA UDI)

by Covidien LP

Identity

Trade Name
Endo GIA FDA UDI
Generic Name
Open-surgery manual linear stapler, reusable FDA UDI
Device Name
Reusable Adapter FDA UDI
Model / Reference
EGIAADAPT FDA UDI
Description
Reusable Adapter FDA UDI

Identifiers

Primary DI / UDI-DI
10884521142800 FDA UDI
510(k) Number
K121510 FDA UDI
FDA Product Code
GDW FDA UDI
GMDN Term
Open-surgery manual linear stapler, reusable 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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Open-surgery manual linear stapler, reusable

Endo GIA 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, reusable.

Cleared under the same submission

K121510 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Covidien LP

Sources (1)

  • FDA UDI 949c57d5-9544-4835-90b0-92969980a280 36 fields · synced May 30, 2026