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FDA 510(k)

IMAGYN MICROLAP(TM) LAPAROSCOPE

K-Number: K944079 · 1995-01-20

ApplicantImagyn Medical, Inc.
Decision Date1995-01-20
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

IMAGYN MICROLAP(TM) LAPAROSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Imagyn Medical, Inc.. It received FDA 510(k) clearance on 1995-01-20 under 510(k) number K944079. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMAGYN MICROLAP(TM) LAPAROSCOPE?

IMAGYN MICROLAP(TM) LAPAROSCOPE is a medical device that received FDA 510(k) clearance on 1995-01-20. The listed applicant is Imagyn Medical, Inc.. The 510(k) number is K944079.

When did IMAGYN MICROLAP(TM) LAPAROSCOPE receive FDA 510(k) clearance?

IMAGYN MICROLAP(TM) LAPAROSCOPE received FDA 510(k) clearance on 1995-01-20, under 510(k) number K944079.

Who is the listed applicant for IMAGYN MICROLAP(TM) LAPAROSCOPE?

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

What is the FDA product code for IMAGYN MICROLAP(TM) LAPAROSCOPE?

The FDA product code for IMAGYN MICROLAP(TM) LAPAROSCOPE is HET.

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Other records listing Imagyn Medical, 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.

K972426MICROSPAN GOLD HYSTEROSCOPE AND MICROSPAN HYSTEROSCOPE SHEATHK970750MICROSPAN INSEMINATION SYSTEMK971255IMAGYN EXPANDABLE LAPAROSCOPIC INTRODUCERK965055IMAGYN MICROLAP AND MICRO LAP-GOLD LAPAROSCOPESK963580IMAGYN FALLOPOSCOPY SYSTEMK961688MICROSPAN HYSTEROSCOPE

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Related Devices (Code: HET)

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.

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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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