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Suction Catheter W/Sterile Water

by Medine Dynacor

510(k) K822510

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK822510 Date13 Oct 1982ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0644-03 FDA Unclassified (pre-2012) initiated 12 Feb 2003

    Some of the kits labeled as latex free contain latex gloves which are properly labeled.

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  • Withdrawn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
GBX
Device Class
Class I
Regulation
21 CFR Part 878.4200
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent