510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K922186Substantially Equivalent

Hem-O-Lok -- Modification

Linvatec Corporation, Research Triangle Pa NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K922186 is the FDA 510(k) clearance record for HEM-O-LOK -- MODIFICATION, a class II device, cleared for Linvatec Corp. on under FDA product code GDW (Staple, Implantable). FDA records list 93 510(k) clearances for Linvatec Corp., from to . As of , FDA records show no recalls naming K922186.

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
Linvatec Corp. P.O. Box 12600, Research Triangle Pa NC
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