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FDA 510(k)

STARGATE FALLOPOSCOPY CATHETER, TRIFURCATED IRRIGATION TUBING

K-Number: K974028 · 1998-01-21

ApplicantConceptus, Inc.
Decision Date1998-01-21
Product CodeMKO
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

STARGATE FALLOPOSCOPY CATHETER, TRIFURCATED IRRIGATION TUBING is the device name listed in this FDA 510(k) record. The listed applicant is Conceptus, Inc.. It received FDA 510(k) clearance on 1998-01-21 under 510(k) number K974028. The device is classified under product code MKO. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STARGATE FALLOPOSCOPY CATHETER, TRIFURCATED IRRIGATION TUBING?

STARGATE FALLOPOSCOPY CATHETER, TRIFURCATED IRRIGATION TUBING is a medical device that received FDA 510(k) clearance on 1998-01-21. The listed applicant is Conceptus, Inc.. The 510(k) number is K974028.

When did STARGATE FALLOPOSCOPY CATHETER, TRIFURCATED IRRIGATION TUBING receive FDA 510(k) clearance?

STARGATE FALLOPOSCOPY CATHETER, TRIFURCATED IRRIGATION TUBING received FDA 510(k) clearance on 1998-01-21, under 510(k) number K974028.

Who is the listed applicant for STARGATE FALLOPOSCOPY CATHETER, TRIFURCATED IRRIGATION TUBING?

The FDA 510(k) record lists Conceptus, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STARGATE FALLOPOSCOPY CATHETER, TRIFURCATED IRRIGATION TUBING?

The FDA product code for STARGATE FALLOPOSCOPY CATHETER, TRIFURCATED IRRIGATION TUBING is MKO.

Related Clinical Trials

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Other records listing Conceptus, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K972210RESECTOSCOPE SAFETY SHEATHK962587CONCEPTUS FALLOPIAN TUBE CATHETEIZATION WITH MICROENDOSCOPY SYSTEMK954164HYSTEROSCOPEK953314CONCEPTUS FALLOPIAN TUBE CATHETERIZATION SYSTEMK932387CONCEPTUS VARI-SOFT CATH/PIROUETTE POSIT MANDRELK932993INTRAUTERINE CATHETER AND INTRODUCER

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Related Devices (Code: MKO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221965FemDx FalloViewFemdx Medsystems, Inc.K963580IMAGYN FALLOPOSCOPY SYSTEMImagyn Medical, Inc.K962587CONCEPTUS FALLOPIAN TUBE CATHETEIZATION WITH MICROENDOSCOPY SYSTEMConceptus, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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