510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K160529Substantially Equivalent

Pledgeted COR-SUTURE QUICK LOAD

Lsi Soultions, Victor NY / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K160529 is the FDA 510(k) clearance record for Pledgeted COR-SUTURE QUICK LOAD, a class II device, cleared for Lsi Soultions on under FDA product code GAW (Suture, Nonabsorbable, Synthetic, Polypropylene). FDA records list one 510(k) clearance for Lsi Soultions. As of , FDA records show no recalls naming K160529.

Clearance record

Decision date
Received
(203 days to decision)
Product code
GAW Suture, Nonabsorbable, Synthetic, Polypropylene
Regulation
21 CFR 878.5010
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Lsi Soultions 7796 Victor-Mendon Rd., Victor NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GAW

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