BIOENTERICS ENDOLUMINA ILLUMINATING BOUGIE
FDA 510(k) clearance K934084 · decided 1993-12-16
Clearance details
- K-number
- K934084
- Device name
- BIOENTERICS ENDOLUMINA ILLUMINATING BOUGIE
- Applicant
- Bioenterics Corp.
- Decision
- Substantially Equivalent
- Date received
- 1993-08-20
- Decision date
- 1993-12-16
- Days to decision
- 118 days
- Clearance type
- Traditional
- Product code
- HMJ
- Device class
- 1
- Regulation number
- 886.1810
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Carpinteria, CA, 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 |
|---|---|---|
| BIOENTRICS ENDOLUMINA ILLUMINATED BOUGIE (K924753) | Bioenterics Corp. | 1992-12-15 |
Recalls involving this device
No recalls on record reference this clearance.