Cleared Traditional

K872282 - FLEXIBLE URETEROSCOPE

K872282 is an FDA 510(k) clearance for FLEXIBLE URETEROSCOPE, manufactured by Intramed Laboratories, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FGB cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K872282 · Intramed Laboratories, Inc. · Gastroenterology & Urology device
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Sep 1987
Decision
90d
Days
Class 2
Risk

K872282 is an FDA 510(k) clearance for the FLEXIBLE URETEROSCOPE. Classified as Ureteroscope And Accessories, Flexible/rigid (product code FGB), Class II - Special Controls.

Submitted by Intramed Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on September 14, 1987 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 Intramed Laboratories, Inc. devices

FDA 510(k) Submission Details - K872282

510(k) Number K872282 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1987
Decision Date September 14, 1987
Days to Decision 90 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
40d faster than avg
Panel avg: 130d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FGB Device Classification - Class 2, Special Controls

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 90
Devices cleared under the same product code (FGB) and FDA review panel - the closest regulatory comparables to K872282.
BARD URETEROSCOPIC DEVICE
K883110 · C.R. Bard, Inc. · Oct 1988
SURGITEK FLEXIBLE URETEROSCOPE SU-7 & SU-9
K880801 · Medical Engineering Corp. · May 1988
SURGITEK ARTICULATING URETEROSCOPE MODEL SU-11
K880802 · Medical Engineering Corp. · May 1988
OLYMPUS RIGID URETERORENOSCOPE
K852888 · Olympus Corp. · Aug 1985
OLYMPUS PF-27M FLEXIBLE URETERORENOSCOPE
K844143 · Olympus Corp. · Jan 1985
MODEL FUS-1, FLEXIBLE URETEROSCOPE
K811535 · American Optical Corp. · Jun 1981