Cleared Traditional

K760170 - INTRAUTERINE SOUND

K760170 is an FDA 510(k) clearance for INTRAUTERINE SOUND, manufactured by G.D. Searle and Co.. The device is a Class 1 Obstetrics & Gynecology device with product code HHM cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K760170 · G.D. Searle and Co. · Obstetrics & Gynecology device
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Jul 1976
Decision
13d
Days
Class 1
Risk

K760170 is an FDA 510(k) clearance for the INTRAUTERINE SOUND, PLASTIC DISPOSABLE. Classified as Sound, Uterine (product code HHM), Class I - General Controls.

Submitted by G.D. Searle and Co. (Mchenry, US). The FDA issued a Cleared decision on July 19, 1976 after a review of 13 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all G.D. Searle and Co. devices

FDA 510(k) Submission Details - K760170

510(k) Number K760170 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1976
Decision Date July 19, 1976
Days to Decision 13 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
147d faster than avg
Panel avg: 160d · This submission: 13d
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.