510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K931103Substantially Equivalent

Stryker Stapler System

Stryker Corp., San Jose CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K931103 is the FDA 510(k) clearance record for STRYKER STAPLER SYSTEM, a class II device, cleared for Stryker Endoscopy on under FDA product code GDW (Staple, Implantable). FDA records list 568 510(k) clearances for STRYKER CORP., from to . As of , FDA records show no recalls naming K931103.

Clearance record

Decision date
Received
(223 days to decision)
Product code
GDW Staple, Implantable
Regulation
21 CFR 878.4750
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Stryker Endoscopy 210 Baypointe Pkwy., San Jose CA
510(k) summary
Statement
Third party review
No

Clearances, product code GDW

Trailing 12 months
4 clearances under product code GDW in the twelve months to November 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GDW, trailing twelve months
MonthClearances
December 20251
January 20260
February 20260
March 20260
April 20261
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260
November 20260