510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K120284Substantially Equivalent

Digitex Suture Delivery System, Digitexpolypropylene Suture Cartridge Size 0, with Needle and without Needle, Digitex

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

K120284 is the FDA 510(k) clearance record for DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEX, a class II device, cleared for Coloplast A/S on under FDA product code NEW (Suture, Surgical, Absorbable, Polydioxanone). FDA records list 414 510(k) clearances for MEDLINE INDUSTRIES, LP - Northfield, from to . As of , FDA records show one recall naming K120284.

Clearance record

Decision date
Received
(113 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
Coloplast A/S 1601 W. River Rd. N., Plymouth MN
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