Cleared Traditional

K962396 - KSEA BIPOLAR GOAGULATING FORCEPS

K962396 is the FDA 510(k) clearance for KSEA BIPOLAR GOAGULATING FORCEPS 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 67-day FDA review.

K962396 · KARL STORZ Endoscopy-America, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
67d
Days
Class 2
Risk

K962396 is an FDA 510(k) clearance for the KSEA BIPOLAR GOAGULATING FORCEPS. 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 August 27, 1996 after a review of 67 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 K962396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1996
Decision Date August 27, 1996
Days to Decision 67 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
22d faster than avg
Panel avg: 89d · This submission: 67d
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 102
Devices cleared under the same product code (EOB) and FDA review panel - the closest regulatory comparables to K962396.
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
KARL STORZ CONTACT MICRO-LARYNGOSCOPES
K963426 · KARL STORZ Endoscopy-America, Inc. · Nov 1996
KSEA UNIMAT PLUS
K962898 · KARL STORZ Endoscopy-America, Inc. · Aug 1996
VISION-SCIENCES DISPOSABLE ENDOSHEATH FOR FLEXIBLE NASOPHARYNGO-LARYNGOSCOPES
K950809 · Vision-Sciences, Inc. · Aug 1996
DISPOSABLE ENDOSHEATH FOR E-F100 FLEXIBLE NASOPHARYNGOSCOPE
K961591 · Vision-Sciences, Inc. · Jul 1996