510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K060471Substantially Equivalent

Fssb Nylon Surgical Sutures

Fssb Chirurgische Nadeln GmbH, Washington DC / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K060471 is the FDA 510(k) clearance record for FSSB NYLON SURGICAL SUTURES, a class II device, cleared for Fssb Chirurgische Nadeln GmbH on under FDA product code GAR (Suture, Nonabsorbable, Synthetic, Polyamide). FDA records list one 510(k) clearance for Fssb Chirurgische Nadeln GmbH. As of , FDA records show no recalls naming K060471.

Clearance record

Decision date
Received
(153 days to decision)
Product code
GAR Suture, Nonabsorbable, Synthetic, Polyamide
Regulation
21 CFR 878.5020
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Fssb Chirurgische Nadeln GmbH 719 A St. NE, Washington DC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GAR

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