NOVY CORNUAL CANNULATION SET
FDA 510(k) clearance K931476 · decided 1995-07-28
Clearance details
- K-number
- K931476
- Device name
- NOVY CORNUAL CANNULATION SET
- Applicant
- Cook Ob/Gyn
- Decision
- Substantially Equivalent
- Date received
- 1993-03-24
- Decision date
- 1995-07-28
- Days to decision
- 856 days
- Clearance type
- Traditional
- Product code
- MOV
- Device class
- 2
- Regulation number
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Spencer, IN, 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 |
|---|---|---|
| Modified Novy Cornual Cannulation Set (K180552) | Cook Incorporated | 2018-07-12 |
| ECHOMARK INTRAUTERINE GUIDING CATHETER (K932436) | Echocath, Inc. | 1995-11-16 |
| OVAMED INTRAUTERINE ACCESS CATHETER (K931534) | Ovamed Corp. | 1995-07-28 |
| CONCEPTUS FALLOPIAN TUBE CATHETERIZATION SYSTEM (K953314) | Conceptus, Inc. | 1995-07-28 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Selective Salpingography Catheter with Beacon Tip Cannula, Manipulator/ Injector, Uterine recall (Z-2621-2016) | Cook Inc. | 2016-08-22 |
| Modified Novy Cornual Cannulation Set with clear tip, G17558, REF J-NCS-504070, Cook OB/GY recall (Z-1137-2010) | Cook Women'S Health | 2010-03-15 |
| Modified Novy Cornual Cannulation Set with clear tip, G17478, REF J-NCS-503570, Cook OB/GY recall (Z-1138-2010) | Cook Women'S Health | 2010-03-15 |