Cleared Traditional

K802315 - UTERINE SOUND

K802315 is an FDA 510(k) clearance for UTERINE SOUND, manufactured by Gynemetrics, Inc.. The device is a Class 1 Obstetrics & Gynecology device with product code HHM cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K802315 · Gynemetrics, Inc. · Obstetrics & Gynecology device
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Jan 1981
Decision
111d
Days
Class 1
Risk

K802315 is an FDA 510(k) clearance for the UTERINE SOUND. Classified as Sound, Uterine (product code HHM), Class I - General Controls.

Submitted by Gynemetrics, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 12, 1981 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - 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 - K802315

510(k) Number K802315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1980
Decision Date January 12, 1981
Days to Decision 111 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
50d faster than avg
Panel avg: 161d · This submission: 111d
Pathway characteristics
Predicate-based equivalence.

HHM Device Classification - Class 1, General Controls

Product Code HHM Sound, Uterine
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 884.4530
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HHM Sound, Uterine

All 9
Devices cleared under the same product code (HHM) and FDA review panel - the closest regulatory comparables to K802315.
TEFLON UTERINE SOUND
K870550 · Cook Ob/Gyn · Mar 1987
UTERINE SOUND
K840380 · Intl. Medical Technologies, Inc. · Apr 1984
AUGROS HYSTEROMETER
K831224 · Axcan Scientific Corp. · Oct 1983
UTERINE SOUND, BURNETT DISPOSABLE
K781766 · C.R. Bard, Inc. · Dec 1978
INTRAUTERINE SOUND, PLASTIC DISPOSABLE
K760170 · G.D. Searle and Co. · Jul 1976
K802315 · UTERINE SOUND
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