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FDA 510(k)

IMAGYN LAPAROSCOPIC INSTRUMENTS

K-Number: K944129 · 1994-10-20

ApplicantImagyn Medical, Inc.
Decision Date1994-10-20
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

IMAGYN LAPAROSCOPIC INSTRUMENTS 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 1994-10-20 under 510(k) number K944129. 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 LAPAROSCOPIC INSTRUMENTS?

IMAGYN LAPAROSCOPIC INSTRUMENTS is a medical device that received FDA 510(k) clearance on 1994-10-20. The listed applicant is Imagyn Medical, Inc.. The 510(k) number is K944129.

When did IMAGYN LAPAROSCOPIC INSTRUMENTS receive FDA 510(k) clearance?

IMAGYN LAPAROSCOPIC INSTRUMENTS received FDA 510(k) clearance on 1994-10-20, under 510(k) number K944129.

Who is the listed applicant for IMAGYN LAPAROSCOPIC INSTRUMENTS?

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 LAPAROSCOPIC INSTRUMENTS?

The FDA product code for IMAGYN LAPAROSCOPIC INSTRUMENTS 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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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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