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Fms 218027

by DePuy Mitek, Inc.

Fms 218027 is an endoscope sheath (FDA Class II; FDA product code HRX, Arthroscope) made by DePuy Mitek, Inc., cleared under FDA 510(k) K041824 on 7 Jan 2005 and listed in FDA GUDID since 12 Oct 2016 (UDI-DI 10886705023783), active as of 23 Oct 2026. 2 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

510(k) K041824

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10886705023783 UDI-DI Date12 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK041824 Date7 Jan 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K041824 decided 7 Jan 2005 Active
  • FDA GUDID UDI-DI 10886705023783 listed 12 Oct 2016 Listed

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0657-2016 FDA Class II initiated 20 Nov 2015
    • Terminated Z-0656-2016 FDA Class II initiated 20 Nov 2015

    Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.

Timeline

4 dated events

  1. Cleared FDA 510(k) K041824
  2. Recall initiated FDA recalls Z-0657-2016
  3. Recall initiated FDA recalls Z-0656-2016
  4. Listed FDA GUDID 10886705023783

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Fms
Generic name
Endoscope sheath, reusable
Model / Ref / Catalog
218027
Primary DI / UDI-DI
10886705023783
510(k) Number
FDA product code
HRX
GMDN term
Endoscope sheath, reusable
Device class
Class II
Regulation number
888.1100
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Endoscope sheath, reusable

Cleared under the same submission (K041824)

Similar devices in this category

Other devices filed under Endoscope sheath, reusable.

Other devices from DePuy Mitek, Inc.

See all devices from DePuy Mitek, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)