Cleared Traditional

K971995 - MEDIVISION SINOSCOPE

K971995 is an FDA 510(k) clearance for MEDIVISION SINOSCOPE, manufactured by Medivision Scope Service Center, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EOB cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K971995 · Medivision Scope Service Center, Inc. · Ear, Nose, Throat device
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Jun 1997
Decision
27d
Days
Class 2
Risk

K971995 is an FDA 510(k) clearance for the MEDIVISION SINOSCOPE. Classified as Nasopharyngoscope (flexible Or Rigid) (product code EOB), Class II - Special Controls.

Submitted by Medivision Scope Service Center, Inc. (Anaheim, US). The FDA issued a Cleared decision on June 26, 1997 after a review of 27 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medivision Scope Service Center, Inc. devices

FDA 510(k) Submission Details - K971995

510(k) Number K971995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1997
Decision Date June 26, 1997
Days to Decision 27 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 90d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EOB Device Classification - Class 2, Special Controls

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 116
Devices cleared under the same product code (EOB) and FDA review panel - the closest regulatory comparables to K971995.
FLEXTIP GRASPER
K972450 · Endius, Inc. · Nov 1997
GREATBATCH SCIENTIFIC MR COMPATIBLE SINUSCOPE
K971375 · Wilson Greatbatch Technologies, Inc. · Oct 1997
KARL STORZ CONTACT NASAL MICRO-ENDOSCOPES
K972855 · KARL STORZ Endoscopy-America, Inc. · Sep 1997
SHARPSITE AC
K965233 · Xomed, Inc. · Apr 1997
SMITH & NEPHEW IMAGES ARTHROSCOPE/ENT ENDOSCOPE
K970247 · Smith & Nephew, Inc. · Mar 1997
IRRIGATION/SUCTION HANDLE AND SHEATH
K963757 · Richard Wolf Medical Instruments Corp. · Nov 1996