510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K030177Substantially Equivalent

Orlon Nonabsorable Surgical Suture Usp

Sri Orion Pharmaceuticals & Sutures, Potomac MD / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K030177 is the FDA 510(k) clearance record for ORLON NONABSORABLE SURGICAL SUTURE USP, a class II device, cleared for Sri Orion Pharmaceuticals & Sutures on under FDA product code GAR (Suture, Nonabsorbable, Synthetic, Polyamide). FDA records list one 510(k) clearance for Sri Orion Pharmaceuticals & Sutures. As of , FDA records show no recalls naming K030177.

Clearance record

Decision date
Received
(185 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
Sri Orion Pharmaceuticals & Sutures 9109 Copenhaver Dr., Potomac MD
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