BIOENTRICS ENDOLUMINA ILLUMINATED BOUGIE
FDA 510(k) clearance K924753 · decided 1992-12-15
Clearance details
- K-number
- K924753
- Device name
- BIOENTRICS ENDOLUMINA ILLUMINATED BOUGIE
- Applicant
- Bioenterics Corp.
- Decision
- Substantially Equivalent
- Date received
- 1992-09-22
- Decision date
- 1992-12-15
- Days to decision
- 84 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
+ Add to Predicate Builder ◉ Watch Bioenterics Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BIOENTERICS ENDOLUMINA ILLUMINATING BOUGIE (K934084) | Bioenterics Corp. | 1993-12-16 |
Recalls involving this device
No recalls on record reference this clearance.