Cleared Traditional

FLEXIBLE BIOPSY CUP FORCEPS (K941158) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K941158 · Surgical Technologies, Inc. · Ear, Nose, Throat device
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Apr 1994
Decision
48d
Days
Class 2
Risk

K941158 is an FDA 510(k) clearance for the FLEXIBLE BIOPSY CUP FORCEPS. Classified as Bronchoscope (flexible Or Rigid) (product code EOQ), Class II - Special Controls.

Submitted by Surgical Technologies, Inc. (Miami Lakes, US). The FDA issued a Cleared decision on April 28, 1994 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4680 - the FDA ear, nose and throat 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 Surgical Technologies, Inc. devices

Submission Details

510(k) Number K941158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1994
Decision Date April 28, 1994
Days to Decision 48 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 89d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EOQ Bronchoscope (flexible Or Rigid)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4680
Definition A Bronchoscope (flexible Or Rigid) And Accessories Is A Tubular Endoscopic Device With Any Of A Group Of Accessory Devices Which Attach To The Bronchoscope And Is Intended To Examine Or Treat The Larynx And Tracheobronchial Tree. If The Device Is Reprocessed, Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - EOQ Bronchoscope (flexible Or Rigid)

All 134
Devices cleared under the same product code (EOQ) and FDA review panel - the closest regulatory comparables to K941158.
OLYMPUS DISPOSABLE BIOPSY FORCEPS
K950636 · Olympus America, Inc. · Feb 1995
11274 AB FLEXIBLE PEDIATRIC BRONCHOSCOPE
K931442 · KARL STORZ Endoscopy-America, Inc. · Jan 1995
KARL STORZ BRONCHOSCOPE ACCESSORIES
K943700 · KARL STORZ Endoscopy-America, Inc. · Aug 1994
EVIS 200 SYSTEM
K931154 · Olympus Corp. · Oct 1993
OLYMPUS DISPOSABLE SUCTION VALVE
K920025 · Olympus Corp. · Mar 1992
OLYMPUS DISPOSABLE BIOPSY VALVE
K911412 · Olympus Corp. · Jun 1991