Cleared Traditional

K791330 - HYSTEROSER

K791330 is an FDA 510(k) clearance for HYSTEROSER, manufactured by A. B. Vacuum Extractor, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIH cleared through the Traditional 510(k) pathway after a 229-day FDA review.

K791330 · A. B. Vacuum Extractor, Inc. · Obstetrics & Gynecology device
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Mar 1980
Decision
229d
Days
Class 2
Risk

K791330 is an FDA 510(k) clearance for the HYSTEROSER. Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by A. B. Vacuum Extractor, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 3, 1980 after a review of 229 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.

FDA 510(k) Submission Details - K791330

510(k) Number K791330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1979
Decision Date March 03, 1980
Days to Decision 229 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 161d · This submission: 229d
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.

K791330 · HYSTEROSER
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