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Blom-Singer Indwelling Low Pressure Voice Prosthes

by Helix Medical, Inc.

510(k) K932120

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK932120 Date15 Apr 1994ClearedStatusActive

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-2909-2026 FDA Class II initiated 17 Jun 2026
    • Ongoing Z-2910-2026 FDA Class II initiated 17 Jun 2026

    Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large Esophageal and Tracheal Flange contains a Large Esophageal Flange.

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  • Withdrawn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
EWL
Device Class
Class II
Regulation
21 CFR Part 874.3730
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

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