Cleared Traditional

SPIRABRUSH CX BIOPSY INSTRUMENT (K011488) - FDA 510(k) Clearance

Class I Obstetrics & Gynecology device.

K011488 · Trylon Corp. · Obstetrics & Gynecology device
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Feb 2002
Decision
283d
Days
Class 1
Risk

K011488 is an FDA 510(k) clearance for the SPIRABRUSH CX BIOPSY INSTRUMENT. Classified as Forceps, Biopsy, Gynecological (product code HFB), Class I - General Controls.

Submitted by Trylon Corp. (Torrance, US). The FDA issued a Cleared decision on February 22, 2002 after a review of 283 days - an extended review 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: 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 Trylon Corp. devices

Submission Details

510(k) Number K011488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2001
Decision Date February 22, 2002
Days to Decision 283 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
123d slower than avg
Panel avg: 160d · This submission: 283d
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.