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HD Mediastinoscope

by Karl Storz Endoscopy-America, Inc. 2 variants

510(k) K202272

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 8 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 8 Oct 2026. What this means

Regulatory status

as of registry sync 8 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK202272 Date11 May 2021ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 8 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  • Withdrawn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
EWY
FDA applicant
Karl Storz Endoscopy America, Inc.
Device Class
Class II
Regulation
21 CFR Part 874.4720
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

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