Cleared Traditional

K926527 - ROTO FIT BIOPSY FORCEPS (FDA 510(k) Clearance)

Class I Obstetrics & Gynecology device.

K926527 · Thomasville Medical Assoc. · Obstetrics & Gynecology device
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Feb 1994
Decision
422d
Days
Class 1
Risk

K926527 is an FDA 510(k) clearance for the ROTO FIT BIOPSY FORCEPS. Classified as Forceps, Biopsy, Gynecological (product code HFB), Class I - General Controls.

Submitted by Thomasville Medical Assoc. (Alpharetta, US). The FDA issued a Cleared decision on February 25, 1994 after a review of 422 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

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Submission Details

510(k) Number K926527 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1992
Decision Date February 25, 1994
Days to Decision 422 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
262d slower than avg
Panel avg: 160d · This submission: 422d
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.