510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K993424Substantially Equivalent

The True Y Clip, the Micro Y Clip, the Laparoscopic Y Clip

Y-Clip Associates, Annapolis MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K993424 is the FDA 510(k) clearance record for THE TRUE Y CLIP, THE MICRO Y CLIP, THE LAPAROSCOPIC Y CLIP, a class II device, cleared for Y-Clip Associates on under FDA product code FZP (Clip, Implantable). FDA records list one 510(k) clearance for Y-Clip Associates. As of , FDA records show no recalls naming K993424.

Clearance record

Decision date
Received
(72 days to decision)
Product code
FZP Clip, Implantable
Regulation
21 CFR 878.4300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Y-Clip Associates 116 Defense Hwy., Annapolis MD
510(k) summary
Statement
Third party review
No

Clearances, product code FZP

Trailing 12 months
5 clearances under product code FZP in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FZP, trailing twelve months
MonthClearances
November 20251
December 20252
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20261
October 20260