CODMAN GAAB NEUROENDOSCOPE
FDA 510(k) clearance K923555 · decided 1993-03-23
Clearance details
- K-number
- K923555
- Device name
- CODMAN GAAB NEUROENDOSCOPE
- Applicant
- Codman & Shurtleff, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-07-17
- Decision date
- 1993-03-23
- Days to decision
- 249 days
- Clearance type
- Traditional
- Product code
- GWB
- Device class
- 1
- Regulation number
- 866.3740
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Randolph, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PNEUMOTACHOGRAPHY SYSTEM (K760816) | Aftercal, Inc. | 1976-10-29 |
Recalls involving this device
No recalls on record reference this clearance.