510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K034029Substantially Equivalent

Ti Clip Applier

Gyrx, LLC, Jacksonville FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K034029 is the FDA 510(k) clearance record for TI CLIP APPLIER, a class II device, cleared for Gyrx, LLC on under FDA product code NJC (Clip, Vas Deferens). FDA's definition for product code NJC reads: "This is an implantable clip intended to ligate the vas deferens. This is more specific than the regulation". FDA records list 2 510(k) clearances for Gyrx, LLC, from to . As of , FDA records show no recalls naming K034029.

Clearance record

Decision date
Received
(67 days to decision)
Product code
NJC Clip, Vas Deferens
Regulation
21 CFR 878.4300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Gyrx, LLC 11222 St. Johns Industrial, Jacksonville FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NJC

Trailing 12 months

FDA records hold no clearances under product code NJC in the trailing twelve months.

FDA records show no clearances under product code NJC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NJC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260