510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K233265Substantially Equivalent

Monotime and Optime R

Peters Surgical, Plymouth MA / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K233265 is the FDA 510(k) clearance record for Monotime and Optime R, a class II device, cleared for Peters Surgical on under FDA product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid). FDA records list 7 510(k) clearances for Peters Surgical, from to . As of , FDA records show no recalls naming K233265.

Clearance record

Decision date
Received
(378 days to decision)
Product code
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Regulation
21 CFR 878.4493
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Peters Surgical 10 Cordage Park Cir., Plymouth MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GAM

Trailing 12 months
5 clearances under product code GAM 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 GAM, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20261
March 20260
April 20260
May 20261
June 20261
July 20260
August 20260
September 20260
October 20260