DISPOSABLE BLADES FOR ARTHROSCOPIC SURGICAL DEVICE
FDA 510(k) clearance K863604 · decided 1986-10-03
Clearance details
- K-number
- K863604
- Device name
- DISPOSABLE BLADES FOR ARTHROSCOPIC SURGICAL DEVICE
- Applicant
- American Edwards Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1986-09-16
- Decision date
- 1986-10-03
- Days to decision
- 17 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Santa Ana, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch American Edwards Laboratories
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.
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 |