COLPO CUP CVC-2000
FDA 510(k) clearance K974563 · decided 1998-03-02
Clearance details
- K-number
- K974563
- Device name
- COLPO CUP CVC-2000
- Applicant
- Clinical Innovations, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-12-05
- Decision date
- 1998-03-02
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- HDP
- Device class
- 2
- Regulation number
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Murray, UT, 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 |
|---|---|---|
| SINGLE CHANNEL BALLOON CANNULA (K974801) | Conkin Surgical Instruments , Ltd. | 1998-07-09 |
| 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.