510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K060465Substantially Equivalent

Premio

Peters Surgical, Bobigny, FR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K060465 is the FDA 510(k) clearance record for PREMIO, a class II device, cleared for Peters Surgical on under FDA product code MXW (Suture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride)). FDA records list 7 510(k) clearances for Peters Surgical, from to . As of , FDA records show no recalls naming K060465.

Clearance record

Decision date
Received
(329 days to decision)
Product code
MXW Suture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride)
Regulation
21 CFR 878.5010
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Peters Surgical 42 Rue Benoit Frachon, Bobigny, FR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MXW

Trailing 12 months

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

FDA records show no clearances under product code MXW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MXW, 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