Cleared Traditional

Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01) (K190797) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K190797 · Reed Medical (Zhejiang) Co., Ltd. · Obstetrics & Gynecology device
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Nov 2019
Decision
235d
Days
Class 2
Risk

K190797 is an FDA 510(k) clearance for the Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01). Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by Reed Medical (Zhejiang) Co., Ltd. (Pinghu, CN). The FDA issued a Cleared decision on November 18, 2019 after a review of 235 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1690 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Reed Medical (Zhejiang) Co., Ltd. devices

Submission Details

510(k) Number K190797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2019
Decision Date November 18, 2019
Days to Decision 235 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 160d · This submission: 235d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HIH Hysteroscope (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1690
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Consultant

Shanghai Qisheng Business Consulting Co., Ltd.
Daniel Qiu

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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