Skip to content

Comfeel Seasorb Dressing

by Coloplast Corp.

510(k) K983519

Comfeel Seasorb Dressing is a Class I device made by Coloplast Corp., cleared under FDA 510(k) K983519 on 30 Dec 1998, active as of 22 Oct 2026. One FDA recall is linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK983519 Date30 Dec 1998ClearedStatusActive

Official records

Recalls

1 recall · FDA

    • Terminated Z-0710-2007 FDA Unclassified (pre-2012) initiated 14 Feb 2007

    Coloplast Corp. is recalling Sea-Clens brands Sea-Clens wound cleaner which were found to have some particulates (foreign materials).

Timeline

2 dated events

  1. Cleared FDA 510(k) K983519
  2. Recall initiated FDA recalls Z-0710-2007

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
KMF
Device class
Class I
Regulation
21 CFR Part 880.5090
Advisory committee
General Hospital
FDA decision
SESE Substantially Equivalent

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Similar devices

Other devices filed under FDA product code KMF (Bandage, Liquid).

Other devices from Coloplast Corp.

See all devices from Coloplast Corp. →