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FDA 510(k)

IMAGYN ENDOSCOPE

K-Number: K951996 · 1995-09-01

ApplicantImagyn Medical, Inc.
Decision Date1995-09-01
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

IMAGYN ENDOSCOPE 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 1995-09-01 under 510(k) number K951996. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMAGYN ENDOSCOPE?

IMAGYN ENDOSCOPE is a medical device that received FDA 510(k) clearance on 1995-09-01. The listed applicant is Imagyn Medical, Inc.. The 510(k) number is K951996.

When did IMAGYN ENDOSCOPE receive FDA 510(k) clearance?

IMAGYN ENDOSCOPE received FDA 510(k) clearance on 1995-09-01, under 510(k) number K951996.

Who is the listed applicant for IMAGYN ENDOSCOPE?

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 ENDOSCOPE?

The FDA product code for IMAGYN ENDOSCOPE is GCJ.

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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: GCJ)

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.

K262397CuratOR EX2742Eizo CorporationK260884UNIDRIVE Select SystemKarl Storz SE & CO. KGK260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony CorporationK261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.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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