Cleared Traditional

K190797 - Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01)

K190797 is an FDA 510(k) clearance for Reedgyn disposable hysteroscope (Model ..., manufactured by Reed Medical (Zhejiang) Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HIH cleared through the Traditional 510(k) pathway after a 235-day FDA review.

K190797 · Reed Medical (Zhejiang) Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K190797

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.

HIH Device Classification - Class 2, Special Controls

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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All 143
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