Cleared Traditional

K051972 - KARL STORZ TRANS-NASAL ESOPHAGOSCOPE

K051972 is the FDA 510(k) clearance for KARL STORZ TRANS-NASAL ESOPHAGOSCOPE by KARL STORZ Endoscopy-America, Inc.. It is a Class 2 Ear, Nose, Throat device (product code EOX) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K051972 · KARL STORZ Endoscopy-America, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
25d
Days
Class 2
Risk

K051972 is an FDA 510(k) clearance for the KARL STORZ TRANS-NASAL ESOPHAGOSCOPE. Classified as Esophagoscope (flexible Or Rigid) (product code EOX), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on August 15, 2005 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4710 - 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 K051972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2005
Decision Date August 15, 2005
Days to Decision 25 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
64d faster than avg
Panel avg: 89d · This submission: 25d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EOX Esophagoscope (flexible Or Rigid)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4710
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 - EOX Esophagoscope (flexible Or Rigid)

All 25
Devices cleared under the same product code (EOX) and FDA review panel - the closest regulatory comparables to K051972.
Cytosponge Cell Collection Device
K142695 · Covidien, LLC · Nov 2014
FLEXIBLE TRANS-NASAL VIDEO ESOPHAGOSCOPE WITH DIGITAL VIDEO PROCESSOR AND DISPOSABLE ENDOSHEATH SYSTEMS
K072088 · Vision-Sciences, Inc. · Aug 2007
ENDOSHEATH SYSTEMS FOR USE WITH VISION-SCIENCES TNE SCOPE
K071903 · Vision-Sciences, Inc. · Aug 2007
TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOSHEATH SYSTEM
K031786 · Vision-Sciences, Inc. · Aug 2003
PRISM ELECTROSCOPE
K953849 · KARL STORZ Endoscopy-America, Inc. · Sep 1995
KARL STORZ ENT NEEDLES, TONSIL SYRINGES & NEEDLES
K951395 · KARL STORZ Endoscopy-America, Inc. · May 1995