Cleared Traditional

SHARPSITE AC (K965233) - FDA 510(k) Clearance

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

K965233 · Xomed, Inc. · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Apr 1997
Decision
94d
Days
Class 2
Risk

K965233 is an FDA 510(k) clearance for the SHARPSITE AC. Classified as Nasopharyngoscope (flexible Or Rigid) (product code EOB), Class II - Special Controls.

Submitted by Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on April 4, 1997 after a review of 94 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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, Inc. devices

Submission Details

510(k) Number K965233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 1996
Decision Date April 04, 1997
Days to Decision 94 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
5d slower than avg
Panel avg: 89d · This submission: 94d
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 65
Devices cleared under the same product code (EOB) and FDA review panel - the closest regulatory comparables to K965233.
KSEA UNIMAT 12
K002700 · KARL STORZ Endoscopy-America, Inc. · Oct 2000
DCI ENDOSCOPE
K984369 · KARL STORZ Endoscopy-America, Inc. · Jan 1999
KARL STORZ CONTACT NASAL MICRO-ENDOSCOPES
K972855 · KARL STORZ Endoscopy-America, Inc. · Sep 1997
SMITH & NEPHEW IMAGES ARTHROSCOPE/ENT ENDOSCOPE
K970247 · Smith & Nephew, Inc. · Mar 1997
KARL STORZ CONTACT MICRO-LARYNGOSCOPES
K963426 · KARL STORZ Endoscopy-America, Inc. · Nov 1996
KSEA BIPOLAR GOAGULATING FORCEPS
K962396 · KARL STORZ Endoscopy-America, Inc. · Aug 1996