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Soft K-Cot(R) SFT-4200

by Histologics, LLC

Soft K-Cot(R) SFT-4200 is a manual wound debridement tool (FDA Class I) made by Histologics, LLC, listed in FDA GUDID since 25 Jul 2021 (UDI-DI 00860275000361), registry data as of 8 Nov 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860275000361 UDI-DI Date25 Jul 2021ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Soft K-Cot(R)
Generic name
Manual wound debridement tool
Model / reference
SFT-4200
Primary DI / UDI-DI
00860275000361
FDA product code
FZS, GEE
GMDN term
Manual wound debridement tool
Device class
Class I
Regulation number
878.4800
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code FZS (Curette, Surgical, General Use).

Other devices from Histologics, LLC

See all devices from Histologics, LLC →

Properties

  • Supplied sterile
  • Single use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)