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Burke Bariatric Treatment System II

by Burke Mobility Products 510(k)

Active United States

510(k) K925576

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK925576 Date4 Jun 1993ClearedStatusActive

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  • Withdrawn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 26 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
FNL
Device Class
Class II
Regulation
21 CFR Part 880.5100
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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