Cleared Traditional

K833297 - BRONCHOSCOPY TUBE W/ULTRA LOCUFF

K833297 is an FDA 510(k) clearance for BRONCHOSCOPY TUBE W/ULTRA LOCUFF, manufactured by Surgitek. The device is a Class 2 Anesthesiology device with product code BTS cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K833297 · Surgitek · Anesthesiology device
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Dec 1983
Decision
95d
Days
Class 2
Risk

K833297 is an FDA 510(k) clearance for the BRONCHOSCOPY TUBE W/ULTRA LOCUFF. Classified as Tube, Bronchial (w/wo Connector) (product code BTS), Class II - Special Controls.

Submitted by Surgitek (Mchenry, US). The FDA issued a Cleared decision on December 27, 1983 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5720 - 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Surgitek devices

FDA 510(k) Submission Details - K833297

510(k) Number K833297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1983
Decision Date December 27, 1983
Days to Decision 95 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 140d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTS Device Classification - Class 2, Special Controls

Product Code BTS Tube, Bronchial (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5720
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.