Cleared Traditional

K885168 - RUBENSTEIN URETERAL STONE FRAGMENT BRUSH

K885168 is an FDA 510(k) clearance for RUBENSTEIN URETERAL STONE FRAGMENT BRUSH, manufactured by Boston Scientific Corp. The device is a Class 2 Gastroenterology & Urology device with product code FGO cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K885168 · Boston Scientific Corp · Gastroenterology & Urology device
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Sep 1989
Decision
269d
Days
Class 2
Risk

K885168 is an FDA 510(k) clearance for the RUBENSTEIN URETERAL STONE FRAGMENT BRUSH. Classified as Dislodger, Stone, Flexible (product code FGO), Class II - Special Controls.

Submitted by Boston Scientific Corp (Watertown, US). The FDA issued a Cleared decision on September 8, 1989 after a review of 269 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4680 - 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 Boston Scientific Corp devices

FDA 510(k) Submission Details - K885168

510(k) Number K885168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1988
Decision Date September 08, 1989
Days to Decision 269 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
138d slower than avg
Panel avg: 131d · This submission: 269d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FGO Device Classification - Class 2, Special Controls

Product Code FGO Dislodger, Stone, Flexible
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4680
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 - FGO Dislodger, Stone, Flexible

All 12
Devices cleared under the same product code (FGO) and FDA review panel - the closest regulatory comparables to K885168.
GRASPING FORCEPS
K914110 · Annex Medical, Inc. · Feb 1992
METAL URETERAL BASKET STONE DISLODGER, HELICAL
K914111 · Annex Medical, Inc. · Feb 1992
METAL URETERAL BASKET STONE DISLODGER, FLAT WIRE
K914112 · Annex Medical, Inc. · Feb 1992
PFISTER-SCHWARTZ STONE RETRIEVER
K771302 · V. Mueller O.V. Baxter Healthcare Corp. · Aug 1977