Skip to content

22097 B-M

by Medtronic PS Medical 2 variants

22097 B-M is a Class II device made by Medtronic PS Medical, cleared under FDA 510(k) K841442 on 19 Apr 1984 and listed in FDA GUDID since 17 Jun 2015 (UDI-DI 00673978236315), active as of 22 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

1 ongoing

This device is named in the recall

Documents

510(k) K841442

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00673978236315 UDI-DI Date17 Jun 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK841442 Date19 Apr 1984DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K841442 decided 19 Apr 1984 Active
  • FDA GUDID UDI-DI 00673978236315 listed 17 Jun 2015 Listed

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-1117-2021 FDA Class II initiated 11 Jan 2021

    Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus

    • Terminated Z-0397-2014 FDA Class II initiated 18 Nov 2013

    Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the Strata II Shunt Assembly Kit because they were found to have label discrepancies.

Timeline

4 dated events

  1. Cleared FDA 510(k) K841442
  2. Recall initiated FDA recalls Z-0397-2014
  3. Listed FDA GUDID 00673978236315
  4. Recall initiated FDA recalls Z-1117-2021

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Ventriculoperitoneal shunt
Model / reference
22097 B-M
Primary DI / UDI-DI
00673978236315
510(k) Number
FDA product code
JXG
GMDN term
Ventriculoperitoneal shunt
Device class
Class II
Regulation number
882.5550
GUDID distribution status
In Commercial Distribution
Size
Length — 8.0 Centimeter
Length — 90.0 Centimeter

Related devices

Category: Ventriculoperitoneal shunt

Cleared under the same submission (K841442)

and 8 more cleared under K841442

Other devices from Medtronic PS Medical

  • Strata® 45808

    Class II

  • StrataMR2 46955MR

    Class II

  • StrataMR2 46957MR

    Class II

  • Innervision 27065 D

    Class II

See all devices from Medtronic PS Medical →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (10, all answered No)