Cleared Traditional

K822382 - U.V.A.C. HANDLER SET

K822382 is the FDA 510(k) clearance for U.V.A.C. HANDLER SET by American Hospital Supply Corp.. It is a Class 2 Obstetrics & Gynecology device (product code HHK) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K822382 · American Hospital Supply Corp. · Obstetrics & Gynecology device
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Aug 1982
Decision
16d
Days
Class 2
Risk

K822382 is an FDA 510(k) clearance for the U.V.A.C. HANDLER SET. Classified as Curette, Suction, Endometrial (and Accessories) (product code HHK), Class II - Special Controls.

Submitted by American Hospital Supply Corp. (Mchenry, US). The FDA issued a Cleared decision on August 25, 1982 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1175 - 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 American Hospital Supply Corp. devices

Submission Details

510(k) Number K822382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1982
Decision Date August 25, 1982
Days to Decision 16 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
144d faster than avg
Panel avg: 160d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HHK Curette, Suction, Endometrial (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1175
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 - HHK Curette, Suction, Endometrial (and Accessories)

All 8
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