Cleared Traditional

K980636 - FIBER OPTIC ENDOILLUMINATION PROBE

K980636 is an FDA 510(k) clearance for FIBER OPTIC ENDOILLUMINATION PROBE, manufactured by Dutch Ophthalmic USA, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FFS cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K980636 · Dutch Ophthalmic USA, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
90d
Days
Class 2
Risk

K980636 is an FDA 510(k) clearance for the FIBER OPTIC ENDOILLUMINATION PROBE. Classified as Image, Illumination, Fiberoptic, For Endoscope (product code FFS), Class II - Special Controls.

Submitted by Dutch Ophthalmic USA, Inc. (Kingston, US). The FDA issued a Cleared decision on May 20, 1998 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Dutch Ophthalmic USA, Inc. devices

FDA 510(k) Submission Details - K980636

510(k) Number K980636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1998
Decision Date May 20, 1998
Days to Decision 90 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 131d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FFS Device Classification - Class 2, Special Controls

Product Code FFS Image, Illumination, Fiberoptic, For Endoscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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.

Regulatory Peers - FFS Image, Illumination, Fiberoptic, For Endoscope

All 14
Devices cleared under the same product code (FFS) and FDA review panel - the closest regulatory comparables to K980636.
SMITH & NEPHEW SUBCUTANEOUS ILLUMINATOR
K991323 · Smith & Nephew, Inc. · Jul 1999
SOLARTEC SOURCE 270, MODEL # 90123
K983714 · Cogent Light Technologies, Inc. · Dec 1998
FIBER OPTIC ENDOILLUMINATION PROBE
K982462 · Microvision, Inc. · Sep 1998
VISTA ILLUMINATION SYSTEM
K970217 · Vista Medical Technologies, Inc. · Apr 1997
KARL STORZ XENON 300 LIGHT SOURCE FOR NON-FLASH APPLICATIONS
K962595 · KARL STORZ Endoscopy-America, Inc. · Sep 1996
KARL STORZ ENDOSCOPY-AMERICA, INC.
K933216 · KARL STORZ Endoscopy-America, Inc. · Sep 1993