510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K043298Substantially Equivalent

Blue Orthocord Suture

DePuy Mitek, Inc., Norwood MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K043298 is the FDA 510(k) clearance record for BLUE ORTHOCORD SUTURE, a class II device, cleared for Depuy Mitek on under FDA product code NEW (Suture, Surgical, Absorbable, Polydioxanone). FDA records list 80 510(k) clearances for Depuy Mitek, from to . As of , FDA records show 6 recalls naming K043298.

Clearance record

Decision date
Received
(10 days to decision)
Product code
NEW Suture, Surgical, Absorbable, Polydioxanone
Regulation
21 CFR 878.4840
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Depuy Mitek 249 Vanderbilt Dr., Norwood MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NEW

Trailing 12 months
6 clearances under product code NEW in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NEW, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20261
July 20261
August 20261
September 20261
October 20260