Cleared Traditional

HYSTEROSCOPE (K934286) - FDA 510(k) Clearance

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

K934286 · Bei Medical Systems Co., Inc. · Obstetrics & Gynecology device
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Jul 1994
Decision
320d
Days
Class 2
Risk

K934286 is an FDA 510(k) clearance for the HYSTEROSCOPE. Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by Bei Medical Systems Co., Inc. (Hackensack, US). The FDA issued a Cleared decision on July 19, 1994 after a review of 320 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Bei Medical Systems Co., Inc. devices

Submission Details

510(k) Number K934286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1993
Decision Date July 19, 1994
Days to Decision 320 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
160d slower than avg
Panel avg: 160d · This submission: 320d
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 Peers - HIH Hysteroscope (and Accessories)

All 170
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