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Soft K-Rette SFT-4500

by Histologics, LLC

Soft K-Rette SFT-4500 is a manual wound debridement tool (FDA Class I; FDA product code FZS, Curette, Surgical, General Use) made by Histologics, LLC, listed in FDA GUDID since 10 Nov 2019 (UDI-DI 00860275000354), 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 Number00860275000354 UDI-DI Date10 Nov 2019ListedStatusListed 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  • Withdrawn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-Rette
Generic name
Manual wound debridement tool
Model / Ref / Catalog
SFT-4500
Primary DI / UDI-DI
00860275000354
FDA product code
FZS
GMDN term
Manual wound debridement tool
Device class
Class I
Regulation number
878.4800
GUDID distribution status
In Commercial Distribution

Related devices

Category: Wound debridement tool

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
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)