510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K091061Substantially Equivalent

Implicitguide Surgical Suture System

Implicitcare, LLC, San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K091061 is the FDA 510(k) clearance record for IMPLICITGUIDE SURGICAL SUTURE SYSTEM, a class II device, cleared for Implicitcare, LLC on under FDA product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene). FDA records list one 510(k) clearance for Implicitcare, LLC. As of , FDA records show no recalls naming K091061.

Clearance record

Decision date
Received
(213 days to decision)
Product code
GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Regulation
21 CFR 878.5000
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Implicitcare, LLC 13221 Maricotte Pl., San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GAT

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