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FDA 510(k)

HYSTEROSCOPE

K-Number: K934286 · 1994-07-19

ApplicantBei Medical Systems Co., Inc.
Decision Date1994-07-19
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

HYSTEROSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Bei Medical Systems Co., Inc.. It received FDA 510(k) clearance on 1994-07-19 under 510(k) number K934286. 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 HYSTEROSCOPE?

HYSTEROSCOPE is a medical device that received FDA 510(k) clearance on 1994-07-19. The listed applicant is Bei Medical Systems Co., Inc.. The 510(k) number is K934286.

When did HYSTEROSCOPE receive FDA 510(k) clearance?

HYSTEROSCOPE received FDA 510(k) clearance on 1994-07-19, under 510(k) number K934286.

Who is the listed applicant for HYSTEROSCOPE?

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

What is the FDA product code for HYSTEROSCOPE?

The FDA product code for HYSTEROSCOPE is HIH.

Related Clinical Trials

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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Other records listing Bei Medical Systems Co., 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.

K971492AUTOMATIC ELECTRONIC HYSTEROSCOPIC INSUFFLATORK950663BEI MEDICAL SYSTEMS MG-1000HS MONOPOLAR GENERATORK940266BEI MEDICAL SYSTEMS' SMOKE EVACUATOR

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

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

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