510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K243580Substantially Equivalent

GraftGun Universal Graft Delivery System (GDS)

Surgentec LLC, Boca Raton FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K243580 is the FDA 510(k) clearance record for GraftGun Universal Graft Delivery System (GDS), a class II device, cleared for SurGenTec, LLC on under FDA product code FMF (Syringe, Piston). FDA records list 29 510(k) clearances for SurGenTec, LLC, from to . As of , FDA records show no recalls naming K243580.

Clearance record

Decision date
Received
(78 days to decision)
Product code
FMF Syringe, Piston
Regulation
21 CFR 880.5860
Device class
Class II
Review panel
General Hospital
Applicant
SurGenTec, LLC 911 Clint More Rd., Boca Raton FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FMF

Trailing 12 months
14 clearances under product code FMF in the twelve months to October 2026, December 2025 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code FMF, trailing twelve months
MonthClearances
November 20251
December 20254
January 20260
February 20261
March 20260
April 20261
May 20261
June 20262
July 20261
August 20263
September 20260
October 20260