Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TRANSERVICAL ENDOSCOPE (HYSTEROSCOPE)

K-Number: K882761 · 1988-09-20

ApplicantIntramed Laboratories, Inc.
Decision Date1988-09-20
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

TRANSERVICAL ENDOSCOPE (HYSTEROSCOPE) is the device name listed in this FDA 510(k) record. The listed applicant is Intramed Laboratories, Inc.. It received FDA 510(k) clearance on 1988-09-20 under 510(k) number K882761. 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 TRANSERVICAL ENDOSCOPE (HYSTEROSCOPE)?

TRANSERVICAL ENDOSCOPE (HYSTEROSCOPE) is a medical device that received FDA 510(k) clearance on 1988-09-20. The listed applicant is Intramed Laboratories, Inc.. The 510(k) number is K882761.

When did TRANSERVICAL ENDOSCOPE (HYSTEROSCOPE) receive FDA 510(k) clearance?

TRANSERVICAL ENDOSCOPE (HYSTEROSCOPE) received FDA 510(k) clearance on 1988-09-20, under 510(k) number K882761.

Who is the listed applicant for TRANSERVICAL ENDOSCOPE (HYSTEROSCOPE)?

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

What is the FDA product code for TRANSERVICAL ENDOSCOPE (HYSTEROSCOPE)?

The FDA product code for TRANSERVICAL ENDOSCOPE (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 Intramed Laboratories, 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.

K953258TITANIUM HEMOSTATIC CLIPK942457GRAFT THROMBECTOMY INSTRUMENTSK931792ARTHROSCOPEK925283VALVULOTOMEK934696ANGIOSCOPEK922114ENDOSCOPIC RETRIEVAL BASKET

View all 14 devices →

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.

↑