Cleared Traditional

K173495 - Single Use Hot Biopsy Forceps FD-231 (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K173495 · Olympus Medical Systems Corp. · Anesthesiology device
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Nov 2018
Decision
382d
Days
Class 2
Risk

K173495 is an FDA 510(k) clearance for the Single Use Hot Biopsy Forceps FD-231. Classified as Forceps, Biopsy, Electric Surgical Hemostasis Within Tracheobronchial Tree (product code QEC), Class II - Special Controls.

Submitted by Olympus Medical Systems Corp. (Hachioji-Shi, JP). The FDA issued a Cleared decision on November 30, 2018 after a review of 382 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 876.4300 - the FDA anesthesiology and respiratory 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K173495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2017
Decision Date November 30, 2018
Days to Decision 382 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
243d slower than avg
Panel avg: 139d · This submission: 382d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QEC Forceps, Biopsy, Electric Surgical Hemostasis Within Tracheobronchial Tree
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4300
Definition An Endoscopic Electrosurgical Forceps And Accessories Used With An Endoscope To Electrosurgically Collect Tissue For Biopsy And To Perform Electrosurgical Hemostasis Within The Tracheobronchial Tree
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 Anesthesiology devices follow this clearance model.