Cleared Traditional

K990334 - KSEA ENDOSCOPE HOLDER (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K990334 · KARL STORZ Endoscopy-America, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
47d
Days
Class 2
Risk

K990334 is an FDA 510(k) clearance for the KSEA ENDOSCOPE HOLDER. Classified as Endoscope Holder (product code OCV), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on March 22, 1999 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology 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 K990334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1999
Decision Date March 22, 1999
Days to Decision 47 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 130d · This submission: 47d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OCV Endoscope Holder
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Hold Endoscope In A Desired Position During Procedures.
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 Gastroenterology & Urology devices follow this clearance model.