510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K983318Substantially Equivalent

Fixation System

General Surgical Innovations, Cupertino CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983318 is the FDA 510(k) clearance record for FIXATION SYSTEM, a class II device, cleared for General Surgical Innovations on under FDA product code GDW (Staple, Implantable). FDA records list 14 510(k) clearances for General Surgical Innovations, from to . As of , FDA records show no recalls naming K983318.

Clearance record

Decision date
Received
(161 days to decision)
Product code
GDW Staple, Implantable
Regulation
21 CFR 878.4750
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
General Surgical Innovations 10460 Bubb Rd., Cupertino CA
510(k) summary
Summary
Third party review
No

Clearances, product code GDW

Trailing 12 months
4 clearances under product code GDW in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GDW, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20261
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260