SINGLE CHANNEL BALLOON CANNULA
FDA 510(k) clearance K974801 · decided 1998-07-09
Clearance details
- K-number
- K974801
- Device name
- SINGLE CHANNEL BALLOON CANNULA
- Applicant
- Conkin Surgical Instruments , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1997-12-22
- Decision date
- 1998-07-09
- Days to decision
- 199 days
- Clearance type
- Traditional
- Product code
- HDP
- Device class
- 2
- Regulation number
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Toronta, Ontario, CA
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Conkin Surgical Instruments
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 |
|---|---|---|
| COLPO CUP CVC-2000 (K974563) | Clinical Innovations, Inc. | 1998-03-02 |
| HYSTERO KIT (K882054) | Zinnanti Surgical Instruments, Inc. | 1988-09-29 |
| HASSON BUEC-3 (K820672) | Bivona Medical Technologies | 1982-07-30 |
Recalls involving this device
No recalls on record reference this clearance.