510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K081060Substantially Equivalent

Ferrofibre Stainless Steel Sutures, Model 610 Series Sizes (Usp) 5-0 to #5

Core Essence Orthopaedics, LLC, Yardley PA / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081060 is the FDA 510(k) clearance record for FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5, a class II device, cleared for Core Essence Orthopaedics, LLC on under FDA product code GAQ (Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile). FDA records list 6 510(k) clearances for Core Essence Orthopaedics, LLC, from to . As of , FDA records show no recalls naming K081060.

Clearance record

Decision date
Received
(254 days to decision)
Product code
GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Regulation
21 CFR 878.4495
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Core Essence Orthopaedics, LLC 301 Oxford Valley Rd., Yardley PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GAQ

Trailing 12 months

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

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