510(k) K932120 ยท EWL Prosthesis, Laryngeal (Taub)
BLOM-SINGER INDWELLING LOW PRESSURE VOICE PROSTHES
| Applicant | Helix Medical, Inc., Santa Barbera CA, US |
| Decision | Substantially Equivalent, Apr 15, 1994 |
| Received | May 3, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K932120
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 6, 2026 | Freudenberg Medical, LLC Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm
REF: 1610-LEF Open, Classified |
EWL | None listed |
| Aug 6, 2026 | Freudenberg Medical, LLC Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm
REF: 1610-LF Open, Classified |
EWL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.