Cleared Traditional

K970107 - INTUBATION ENDOSCOPE AND INTRODUCER SHEATH

K970107 is an FDA 510(k) clearance for INTUBATION ENDOSCOPE AND INTRODUCER SHEATH, manufactured by Urohealth Systems, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EOQ cleared through the Traditional 510(k) pathway after a 309-day FDA review.

K970107 · Urohealth Systems, Inc. · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Nov 1997
Decision
309d
Days
Class 2
Risk

K970107 is an FDA 510(k) clearance for the INTUBATION ENDOSCOPE AND INTRODUCER SHEATH. Classified as Bronchoscope (flexible Or Rigid) (product code EOQ), Class II - Special Controls.

Submitted by Urohealth Systems, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on November 18, 1997 after a review of 309 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Urohealth Systems, Inc. devices

FDA 510(k) Submission Details - K970107

510(k) Number K970107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1997
Decision Date November 18, 1997
Days to Decision 309 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
220d slower than avg
Panel avg: 89d · This submission: 309d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EOQ Device Classification - Class 2, Special Controls

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 188
Devices cleared under the same product code (EOQ) and FDA review panel - the closest regulatory comparables to K970107.
MODIFICATION TO WILSON-COOK LUNG BIOPSY NEEDLE
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MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) COMBINATION CYTOLOGY/HISTOLOGY PROCEDURAL KIT
K983122 · Mill-Rose Laboratory · Oct 1998
MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) CYTOLOGY PROCEDURAL KIT
K983124 · Mill-Rose Laboratory · Oct 1998
VISION-SCIENCES MODEL B-F100 BRONCHOSCOPE WITH MODEL BS-F21 DISPOSABLE ENDOSHEATH
K963795 · Vision-Sciences, Inc. · Dec 1996
TBAN
K963252 · Boston Scientific Corp · Sep 1996
BF 240/P240/IT240 BRONCHOVIDEOSCOPE & ACCESSORIES
K963033 · Olympus America, Inc. · Sep 1996