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Ehtox Gastric Lavage Kit #2050 & #2070

by Ethox Corp.

510(k) K812648

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 NumberK812648 Date29 Sep 1981ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0271-2012 FDA Unclassified (pre-2012) initiated 25 Mar 2011

    Ethox Tum-E-Vac Gastric Lavage Kit #2075, Lot Number 031123255 was labeled with expiration date symbol and date of 2010/10 on the unit product label. The carton was labeled with a manufacturing date symbol and date of 2010/10. The Ethox Tum-E-Vac Gastric Lavage Kit #2075 does not have an expiration date.

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  • Withdrawn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
KNT
Device Class
Class II
Regulation
21 CFR Part 876.5980
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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