510(k) K962587

Device: CONCEPTUS FALLOPIAN TUBE CATHETEIZATION WITH MICROENDOSCOPY SYSTEM
Applicant: CONCEPTUS, INC.
510(k) number: K962587
Product code: MKO
Decision: Substantially Equivalent (SESE)
Decision date: 1997-01-31
Date received: 1996-07-01
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: NANCY NADDAFF
Address: 1021 Howard Ave. San Carlos CA US 94070 94070

Source Documents#

Other 510(k) Records For Product Code MKO #

510(k), Device, Applicant table
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
K963580	IMAGYN FALLOPOSCOPY SYSTEM	Imagyn Medical, Inc.	1997-01-31

Legacy Summary#

summary

FDA Review#

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