STARGATE FALLOPOSCOPY CATHETER, TRIFURCATED IRRIGATION TUBING
FDA 510(k) clearance K974028 · decided 1998-01-21
Clearance details
- K-number
- K974028
- Device name
- STARGATE FALLOPOSCOPY CATHETER, TRIFURCATED IRRIGATION TUBING
- Applicant
- Conceptus, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-10-23
- Decision date
- 1998-01-21
- Days to decision
- 90 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
+ Add to Predicate Builder ◉ Watch Conceptus
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
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 |
|---|---|---|
| FemDx FalloView (K221965) | Femdx Medsystems, Inc. | 2023-03-17 |
| CONCEPTUS FALLOPIAN TUBE CATHETEIZATION WITH MICROENDOSCOPY SYSTEM (K962587) | Conceptus, Inc. | 1997-01-31 |
| IMAGYN FALLOPOSCOPY SYSTEM (K963580) | Imagyn Medical, Inc. | 1997-01-31 |
Recalls involving this device
No recalls on record reference this clearance.