510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K093112Substantially Equivalent

Digitex Suture Delivery System, Model 52025, Digitex Suture Cartridge (Size O), Model 52026, Digitex Suture Cartridge

MEDLINE INDUSTRIES, LP - Northfield, Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K093112 is the FDA 510(k) clearance record for DIGITEX SUTURE DELIVERY SYSTEM, MODEL 52025, DIGITEX SUTURE CARTRIDGE (SIZE O), MODEL 52026, DIGITEX SUTURE CARTRIDGE, a class II device, cleared for Coloplast Manufacturing Us, LLC on under FDA product code GAW (Suture, Nonabsorbable, Synthetic, Polypropylene). FDA records list 414 510(k) clearances for MEDLINE INDUSTRIES, LP - Northfield, from to . As of , FDA records show no recalls naming K093112.

Clearance record

Decision date
Received
(123 days to decision)
Product code
GAW Suture, Nonabsorbable, Synthetic, Polypropylene
Regulation
21 CFR 878.5010
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Coloplast Manufacturing Us, LLC 1601 W. River Rd., Minneapolis MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GAW

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