Cleared Traditional

K862551 - FUNS-10

K862551 is the FDA 510(k) clearance for FUNS-10 by Reichert-Jung, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FGB) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K862551 · Reichert-Jung, Inc. · Gastroenterology & Urology device
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Sep 1986
Decision
71d
Days
Class 2
Risk

K862551 is an FDA 510(k) clearance for the FUNS-10, FUNS-11. Classified as Ureteroscope And Accessories, Flexible/rigid (product code FGB), Class II - Special Controls.

Submitted by Reichert-Jung, Inc. (Southbridge, US). The FDA issued a Cleared decision on September 12, 1986 after a review of 71 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 Reichert-Jung, Inc. devices

Submission Details

510(k) Number K862551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1986
Decision Date September 12, 1986
Days to Decision 71 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 130d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FGB Ureteroscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Perform Various Diagnostic And Therapeutic Procedures Within The Urinary Tract. For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data 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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FGB Ureteroscope And Accessories, Flexible/rigid

All 81
Devices cleared under the same product code (FGB) and FDA review panel - the closest regulatory comparables to K862551.
BARD 3000 PLUS URETEROSCOPY SYSTEM
K911411 · C.R. Bard, Inc. · Apr 1991
BARD SHORT RIGID URETEROSCOPE
K900813 · C.R. Bard, Inc. · May 1990
BARD URETEROSCOPIC DEVICE
K883110 · C.R. Bard, Inc. · Oct 1988
OLYMPUS RIGID URETERORENOSCOPE
K852888 · Olympus Corp. · Aug 1985
OLYMPUS PF-27M FLEXIBLE URETERORENOSCOPE
K844143 · Olympus Corp. · Jan 1985