Modified Novy Cornual Cannulation Set
FDA 510(k) clearance K180552 · decided 2018-07-12
Clearance details
- K-number
- K180552
- Device name
- Modified Novy Cornual Cannulation Set
- Applicant
- Cook Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2018-03-01
- Decision date
- 2018-07-12
- Days to decision
- 133 days
- Clearance type
- Special
- Product code
- MOV
- Device class
- 2
- Regulation number
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Bloomington, 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 |
|---|---|---|
| ECHOMARK INTRAUTERINE GUIDING CATHETER (K932436) | Echocath, Inc. | 1995-11-16 |
| OVAMED INTRAUTERINE ACCESS CATHETER (K931534) | Ovamed Corp. | 1995-07-28 |
| NOVY CORNUAL CANNULATION SET (K931476) | Cook Ob/Gyn | 1995-07-28 |
| CONCEPTUS FALLOPIAN TUBE CATHETERIZATION SYSTEM (K953314) | Conceptus, Inc. | 1995-07-28 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| COOK CHORIONIC VILLUS SAMPLING SET (P900007/S005) | Cook Incorporated | 2009-04-02 |
| COOK CHORIONIC VILLUS SAMPLING SET (P900007/S006) | Cook Incorporated | 2009-03-05 |
| COOK CHORIONIC VILLUS SAMPLING SET (P900007/S004) | Cook Incorporated | 2008-05-08 |
| COOK CHORIONIC VILLUS SAMPLING (CVS) SET (P900007/S002) | Cook Incorporated | 2000-06-12 |
| COOK CHORIONIC VILLUS SAMPLING SET (P900007/S001) | Cook Incorporated | 1998-07-08 |
| COOK CHORIONIC VILLUS SAMPLING SET (P900007) | Cook Incorporated | 1994-09-30 |