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Capsule Delivery Device, 160cm, Model 711143; Capsule Delivery Device, 210cm, Model 711144

by United States Endoscopy Group, Inc. 510(k)

Active United States

510(k) K040494

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK040494 Date23 Jun 2004ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 10 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
NEZ
Device Class
Class II
Regulation
21 CFR Part 876.1300
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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