510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K141007Substantially Equivalent

Demesteel (Stainless Steel) Non-Absorbable Suture

Demetech Corp., Miami Lakes FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K141007 is the FDA 510(k) clearance record for DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE, a class II device, cleared for Demetech Corp. on under FDA product code GAQ (Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile). FDA records list 16 510(k) clearances for Demetech Corp., from to . As of , FDA records show no recalls naming K141007.

Clearance record

Decision date
Received
(160 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
Demetech Corp. 14175 NW 60th Ave., Miami Lakes FL
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