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Takane Auto Enemator (1200R +2 more) - G1300SR*

by Eisai U.S.A., Inc.

510(k) K864835

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 11 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK864835 Date11 Feb 1987ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 11 Oct 2026.

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  • Withdrawn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
FCD
Models / Variants
G1300SR*
Device Class
Class I
Regulation
21 CFR Part 876.5210
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent