CONCEPTUS FALLOPIAN TUBE CATHETEIZATION WITH MICROENDOSCOPY SYSTEM
FDA 510(k) clearance K962587 · decided 1997-01-31
Clearance details
- K-number
- K962587
- Device name
- CONCEPTUS FALLOPIAN TUBE CATHETEIZATION WITH MICROENDOSCOPY SYSTEM
- Applicant
- Conceptus, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-07-01
- Decision date
- 1997-01-31
- Days to decision
- 214 days
- Clearance type
- Traditional
- Product code
- MKO
- Device class
- 2
- Regulation number
- 884.1690
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- San Carlos, CA, 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 |
|---|---|---|
| FemDx FalloView (K221965) | Femdx Medsystems, Inc. | 2023-03-17 |
| STARGATE FALLOPOSCOPY CATHETER, TRIFURCATED IRRIGATION TUBING (K974028) | Conceptus, Inc. | 1998-01-21 |
| IMAGYN FALLOPOSCOPY SYSTEM (K963580) | Imagyn Medical, Inc. | 1997-01-31 |
Recalls involving this device
No recalls on record reference this clearance.