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FDA 510(k)

FLEXIBLE IMMERSIBLE HYSTEROSCOPE

K-Number: K892390 · 1990-02-02

ApplicantSchott Fiber Optics, Inc.
Decision Date1990-02-02
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FLEXIBLE IMMERSIBLE HYSTEROSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Schott Fiber Optics, Inc.. It received FDA 510(k) clearance on 1990-02-02 under 510(k) number K892390. 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 FLEXIBLE IMMERSIBLE HYSTEROSCOPE?

FLEXIBLE IMMERSIBLE HYSTEROSCOPE is a medical device that received FDA 510(k) clearance on 1990-02-02. The listed applicant is Schott Fiber Optics, Inc.. The 510(k) number is K892390.

When did FLEXIBLE IMMERSIBLE HYSTEROSCOPE receive FDA 510(k) clearance?

FLEXIBLE IMMERSIBLE HYSTEROSCOPE received FDA 510(k) clearance on 1990-02-02, under 510(k) number K892390.

Who is the listed applicant for FLEXIBLE IMMERSIBLE HYSTEROSCOPE?

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

What is the FDA product code for FLEXIBLE IMMERSIBLE HYSTEROSCOPE?

The FDA product code for FLEXIBLE IMMERSIBLE 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Schott Fiber Optics, 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.

K892000FLEXIBLE IMMERSIBLE SIGMOIDOSCOPE

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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