AMER. EDWARDS LAB FLEXISCOPE
FDA 510(k) clearance K842410 · decided 1984-11-05
Clearance details
- K-number
- K842410
- Device name
- AMER. EDWARDS LAB FLEXISCOPE
- Applicant
- American Edwards Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1984-06-19
- Decision date
- 1984-11-05
- Days to decision
- 139 days
- Clearance type
- Traditional
- Product code
- HRK
- Device class
- 1
- Regulation number
- 886.4855
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Santa Ana, 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 |
|---|---|---|
| EVANS ARM AND HAND REST (K760697) | Alcon Laboratories | 1976-11-02 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| GARREN GASTRIC BUBBLE (P840025/S011) | American Edwards Laboratories | 1987-03-17 |
| GARREN GASTRIC BUBBLE (P840025/S008) | American Edwards Laboratories | 1986-10-16 |
| GARREN GASTRIC BUBBLE (P840025/S006) | American Edwards Laboratories | 1986-07-25 |
| GARREN{TM}-EDWARDS GASTRIC BUBBLE (P840025/S005) | American Edwards Laboratories | 1986-05-12 |
| GARREN GASTRIC BUBBLE (P840025/S003) | American Edwards Laboratories | 1986-01-23 |
| GARREN GASTRIC BUBBLE (P840025/S002) | American Edwards Laboratories | 1986-01-23 |
| GARREN GASTRIC BUBBLE (P840025/S004) | American Edwards Laboratories | 1986-01-23 |
| GARREN GASTRIC BUBBLE (P840025/S001) | American Edwards Laboratories | 1985-12-18 |