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Medicomp Flexi-Smooth Wound Drainage Catheter

by Medical Components, Inc. United States(FDA 510(k) applicant) 510(k)

510(k) K960426 Product code GBW

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK960426 Date21 Mar 1996ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
GBW
Device Class
Class I
Regulation
21 CFR Part 878.4200
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K960426 24 fields · synced 22 Oct 2026