Cleared Traditional

K802458 - KEVORKIAN-YOUNGE BIOPSY CURETTE #90-6611

K802458 is an FDA 510(k) clearance for KEVORKIAN-YOUNGE BIOPSY CURETTE #90-6611, manufactured by J. Sklar Mfg. Co., Inc.. The device is a Class 1 Obstetrics & Gynecology device with product code HFB cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K802458 · J. Sklar Mfg. Co., Inc. · Obstetrics & Gynecology device
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Jan 1981
Decision
96d
Days
Class 1
Risk

K802458 is an FDA 510(k) clearance for the KEVORKIAN-YOUNGE BIOPSY CURETTE #90-6611. Classified as Forceps, Biopsy, Gynecological (product code HFB), Class I - General Controls.

Submitted by J. Sklar Mfg. Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on January 12, 1981 after a review of 96 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.

View all J. Sklar Mfg. Co., Inc. devices

FDA 510(k) Submission Details - K802458

510(k) Number K802458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1980
Decision Date January 12, 1981
Days to Decision 96 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
64d faster than avg
Panel avg: 160d · This submission: 96d
Pathway characteristics
Predicate-based equivalence.

HFB Device Classification - Class 1, General Controls

Product Code HFB Forceps, Biopsy, Gynecological
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.