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FDA 510(k)

IMAGYN HYSTEROSCOPE SHEATHS

K-Number: K952032 · 1995-10-31

ApplicantImagyn Medical, Inc.
Decision Date1995-10-31
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

IMAGYN HYSTEROSCOPE SHEATHS 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 1995-10-31 under 510(k) number K952032. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMAGYN HYSTEROSCOPE SHEATHS?

IMAGYN HYSTEROSCOPE SHEATHS is a medical device that received FDA 510(k) clearance on 1995-10-31. The listed applicant is Imagyn Medical, Inc.. The 510(k) number is K952032.

When did IMAGYN HYSTEROSCOPE SHEATHS receive FDA 510(k) clearance?

IMAGYN HYSTEROSCOPE SHEATHS received FDA 510(k) clearance on 1995-10-31, under 510(k) number K952032.

Who is the listed applicant for IMAGYN HYSTEROSCOPE SHEATHS?

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 HYSTEROSCOPE SHEATHS?

The FDA product code for IMAGYN HYSTEROSCOPE SHEATHS is HIH.

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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: HIH)

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.

K254252UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10)Karl Storz SE & CO. KGK261102UNIDRIVE Select SystemKarl Storz SE & CO. KGK254294Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30, GYUT-A 14.4- 0, GYUT-A 14.4- 12,GYUT-A 14.4- 22, GYUT-A 14.4- 30, GYUT-B 15- 0, GYUT-B 15- 12, GYUT-B 15-22, GYUT-B 15- 30)Zhejiang Geyi Medical Instrument Co., Ltd.K260984HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)Axora Medical, Inc.K253020Strauss Surgical Resection InstrumentsAmerican Medical Endoscopy, Inc.K254050Manual Tissue Removal DeviceSuzhou AcuVu Medical Technology Co., Ltd.

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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