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Flex-Neck Pd Catheter

by Janin Group, Inc.

510(k) K970159

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

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK970159 Date5 Sep 1997ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2823-2018 FDA Class II initiated 20 Dec 2017

    Mix-up between adult and pediatrics PD catheter.

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  • Withdrawn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
FJS
Device Class
Class II
Regulation
21 CFR Part 876.5630
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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