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FDA 510(k)

ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US)

K-Number: K240401 · 2024-07-26

ApplicantOrigyn Medical Technology (Hangzhou) Co., Ltd.
Decision Date2024-07-26
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US) is a medical device manufactured by Origyn Medical Technology (Hangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2024-07-26 under approval number K240401. 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 ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US)?

ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US) is a medical device that received FDA 510(k) clearance on 2024-07-26. It is manufactured by Origyn Medical Technology (Hangzhou) Co., Ltd.. The 510(k) number is K240401.

When was ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US) approved by the FDA?

ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US) received FDA 510(k) clearance on 2024-07-26, under approval number K240401.

What company makes ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US)?

ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US) is manufactured by Origyn Medical Technology (Hangzhou) Co., Ltd..

What is the FDA product code for ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US)?

The FDA product code for ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US) is HIH.

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Related PubMed Literature

PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) PMID: 39941212 Artificial Intelligence-Empowered Radiology-Current Status and Critical Review. Diagnostics (Basel, Switzerland) (2025)

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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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