Cleared Traditional

ADULT RESECTOSCOPE (K890328) - FDA 510(k) Clearance

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

K890328 · Circon Video · Obstetrics & Gynecology device
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Feb 1990
Decision
379d
Days
Class 2
Risk

K890328 is an FDA 510(k) clearance for the ADULT RESECTOSCOPE. Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by Circon Video (Stanford, US). The FDA issued a Cleared decision on February 6, 1990 after a review of 379 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 Circon Video devices

Submission Details

510(k) Number K890328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1989
Decision Date February 06, 1990
Days to Decision 379 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
219d slower than avg
Panel avg: 160d · This submission: 379d
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
Devices cleared under the same product code (HIH) and FDA review panel - the closest regulatory comparables to K890328.
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