Cleared Traditional

K002700 - KSEA UNIMAT 12

K002700 is the FDA 510(k) clearance for KSEA UNIMAT 12 by KARL STORZ Endoscopy-America, Inc.. It is a Class 2 Ear, Nose, Throat device (product code EOB) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K002700 · KARL STORZ Endoscopy-America, Inc. · Ear, Nose, Throat device
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Oct 2000
Decision
49d
Days
Class 2
Risk

K002700 is an FDA 510(k) clearance for the KSEA UNIMAT 12. Classified as Nasopharyngoscope (flexible Or Rigid) (product code EOB), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on October 18, 2000 after a review of 49 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 KARL STORZ Endoscopy-America, Inc. devices

Submission Details

510(k) Number K002700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2000
Decision Date October 18, 2000
Days to Decision 49 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 89d · This submission: 49d
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 100
Devices cleared under the same product code (EOB) and FDA review panel - the closest regulatory comparables to K002700.
VISION SCIENCES ENDOSHEATH SYSTEM
K012543 · Vision-Sciences, Inc. · Jul 2002
VISERA RHINLARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V
K021073 · Olympus America, Inc. · May 2002
KSEA CLEARVISION LENS IRRIGATION SYSTEM
K013838 · KARL STORZ Endoscopy-America, Inc. · Jan 2002
FLEXIBLE NASOPHARYNGO-LARYNGOSCOPES, FLEXIBLE BRONCHOSCOPE
K992526 · Richard Wolf Medical Instruments Corp. · Sep 1999
ENDOSHEATH
K990354 · Vision-Sciences, Inc. · Mar 1999
DCI ENDOSCOPE
K984369 · KARL STORZ Endoscopy-America, Inc. · Jan 1999