BLOM-SINGER INDWELLING LOW PRESSURE VOICE PROSTHES— 510(k) K932120
Substantially EquivalentHelix Medical, Inc.
FDA 510(k) clearance K932120 for BLOM-SINGER INDWELLING LOW PRESSURE VOICE PROSTHES, Substantially Equivalent on 1994-04-15. Applicant: Helix Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Helix Medical, Inc.
- Product code
- Code EWL
- Device class
- Class 2
- Regulation
- 21 CFR 874.3730
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Barbera, CA, US
Recent devices under product code EWL
view allMore clearances from Helix Medical, Inc.
view all- K023259 — INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200
- K991587 — BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS
- K945287 — INHEALTH BLOM-SINGER INDWELLING VALVED INSERT ACCESSORY DEVICE
- K945288 — INHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICE
- K932163 — BLOM-SINGER VOICE PROSTHESIS FLUSHING PIPET
Adverse events under product code EWL
product code EWL- Death
- 2
- Total
- 2
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K932120
K-number listed on FDA's recall record- Z-2909-2026 — Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF
- Z-2910-2026 — Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K932120.
Data sourced from openFDA. This site is unofficial and independent of the FDA.