Cleared Traditional

K933598 - ENDOSTAR(TM) STYLET

K933598 is an FDA 510(k) clearance for ENDOSTAR(TM) STYLET, manufactured by Fiberoptic Medical Products, Inc.. The device is a Class 1 Anesthesiology device with product code BSR cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K933598 · Fiberoptic Medical Products, Inc. · Anesthesiology device
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Jan 1994
Decision
183d
Days
Class 1
Risk

K933598 is an FDA 510(k) clearance for the ENDOSTAR(TM) STYLET. Classified as Stylet, Tracheal Tube (product code BSR), Class I - General Controls.

Submitted by Fiberoptic Medical Products, Inc. (Allentown, US). The FDA issued a Cleared decision on January 25, 1994 after a review of 183 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5790 - 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 Fiberoptic Medical Products, Inc. devices

FDA 510(k) Submission Details - K933598

510(k) Number K933598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1993
Decision Date January 25, 1994
Days to Decision 183 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 140d · This submission: 183d
Pathway characteristics
Predicate-based equivalence.

BSR Device Classification - Class 1, General Controls

Product Code BSR Stylet, Tracheal Tube
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5790
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.

Regulatory Peers - BSR Stylet, Tracheal Tube

All 18
Devices cleared under the same product code (BSR) and FDA review panel - the closest regulatory comparables to K933598.
RUSCH ENDOTRACHEAL TUBE STYLET
K952100 · Rusch, Inc. · Aug 1995
AIRGUIDE STYLETTE
K950713 · Polamedco, Inc. · May 1995
FLEXTITIP STYLETTE
K950380 · Polamedco, Inc. · Feb 1995
AUGUSTINE STYLET
K920468 · Augustine Medical, Inc. · Apr 1992
AUGUSTINE GUIDE(TM) KIT
K912690 · Augustine Medical, Inc. · Sep 1991
AUGUSTINE STYLET
K910659 · Augustine Medical, Inc. · May 1991