510(k) K963580
- Device
- IMAGYN FALLOPOSCOPY SYSTEM
- Applicant
- IMAGYN MEDICAL, INC.
- 510(k) number
- K963580
- Product code
- MKO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-01-31
- Date received
- 1996-09-06
- Regulation
- 884.1690
- Classification name
- Falloposcope
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DEBRA A RINDERER
- Address
- 27651 La Paz Rd. Laguna Niguel CA US 92656 92656
Source Documents#
Other 510(k) Records For Product Code MKO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K221965 | FemDx FalloView | Femdx Medsystems, Inc. | 2023-03-17 |
| K974028 | STARGATE FALLOPOSCOPY CATHETER, TRIFURCATED IRRIGATION TUBING | Conceptus, Inc. | 1998-01-21 |
| K962587 | CONCEPTUS FALLOPIAN TUBE CATHETEIZATION WITH MICROENDOSCOPY SYSTEM | Conceptus, Inc. | 1997-01-31 |
Legacy Summary#
summary
FDA Review#
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