Cleared Traditional

GYNE-SHEAR CERVICAL BIOPSY INSTRUMENT W/DISPIS TIP (K852357) - FDA 510(k) Clearance

Class I Obstetrics & Gynecology device.

K852357 · Gyneco, Inc. · Obstetrics & Gynecology device
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Jul 1985
Decision
32d
Days
Class 1
Risk

K852357 is an FDA 510(k) clearance for the GYNE-SHEAR CERVICAL BIOPSY INSTRUMENT W/DISPIS TIP. Classified as Forceps, Biopsy, Gynecological (product code HFB), Class I - General Controls.

Submitted by Gyneco, Inc. (Somerville, US). The FDA issued a Cleared decision on July 5, 1985 after a review of 32 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 Gyneco, Inc. devices

Submission Details

510(k) Number K852357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1985
Decision Date July 05, 1985
Days to Decision 32 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
128d faster than avg
Panel avg: 160d · This submission: 32d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.