Cleared Traditional

K933672 - XOMED-TREACE SCOPESHEATH

K933672 is the FDA 510(k) clearance for XOMED-TREACE SCOPESHEATH by Xomed-Treace, Inc.. It is a Class 2 Ear, Nose, Throat device (product code EOB) cleared through the Traditional 510(k) pathway after a 355-day FDA review.

K933672 · Xomed-Treace, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
355d
Days
Class 2
Risk

K933672 is an FDA 510(k) clearance for the XOMED-TREACE SCOPESHEATH. Classified as Nasopharyngoscope (flexible Or Rigid) (product code EOB), Class II - Special Controls.

Submitted by Xomed-Treace, Inc. (Jacksonville, US). The FDA issued a Cleared decision on July 18, 1994 after a review of 355 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 874.4760 - 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 Xomed-Treace, Inc. devices

Submission Details

510(k) Number K933672 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1993
Decision Date July 18, 1994
Days to Decision 355 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
266d slower than avg
Panel avg: 89d · This submission: 355d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EOB Nasopharyngoscope (flexible Or Rigid)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4760
Definition 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 - EOB Nasopharyngoscope (flexible Or Rigid)

All 77
Devices cleared under the same product code (EOB) and FDA review panel - the closest regulatory comparables to K933672.
KARL STORZ OPTICAL VIDEO TONGUE DEPRESSOR
K944296 · KARL STORZ Endoscopy-America, Inc. · Oct 1994
NASAL ENDOSCOPY & SINUSCOPY HAND INSTRUMENTS
K943665 · Olympus America, Inc. · Oct 1994
FORCEPS, PUNCHES, SCISSORS
K943074 · KARL STORZ Endoscopy-America, Inc. · Aug 1994
ACCESSORIES FOR ENDOSCOPES FOR SINUS SURGERY
K932988 · Smith & Nephew Richards, Inc. · Jul 1993
NASAL/PARANASAL ENDOSCOPE
K930931 · Storz Instrument Co. · May 1993
FLEXIBLE NASOPHARYNGOSCOPE
K896297 · Jedmed Instrument Co. · Jan 1990