FLEXIBLE VISUALIZATION CATHETER
FDA 510(k) clearance K862872 · decided 1986-10-24
Clearance details
- K-number
- K862872
- Device name
- FLEXIBLE VISUALIZATION CATHETER
- Applicant
- American Edwards Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1986-07-30
- Decision date
- 1986-10-24
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- FEI
- Device class
- 1
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- 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 |
|---|---|---|
| M-LENS (THIRTY DEGREE ENDOSCOPE) (K873795) | Opto Vision, Inc. | 1988-01-14 |
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 |