SURGICAL STIMULATORS
FDA 510(k) clearance K110422 · decided 2011-05-26
Clearance details
- K-number
- K110422
- Device name
- SURGICAL STIMULATORS
- Applicant
- Technomed Europe
- Decision
- Substantially Equivalent
- Date received
- 2011-02-14
- Decision date
- 2011-05-26
- Days to decision
- 101 days
- Clearance type
- Traditional
- Product code
- ETN
- Device class
- 2
- Regulation number
- 874.1820
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Maastricht-Airport, NL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| NEUROSIGN Disposable Stimulating Dissector, REF 5888-00 recall (Z-3131-2024) | Technomed Europe | 2024-09-12 |