Cleared Traditional

K900813 - BARD SHORT RIGID URETEROSCOPE

K900813 is the FDA 510(k) clearance for BARD SHORT RIGID URETEROSCOPE by C.R. Bard, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FGB) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K900813 · C.R. Bard, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
May 1990
Decision
85d
Days
Class 2
Risk

K900813 is an FDA 510(k) clearance for the BARD SHORT RIGID URETEROSCOPE. Classified as Ureteroscope And Accessories, Flexible/rigid (product code FGB), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on May 17, 1990 after a review of 85 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K900813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1990
Decision Date May 17, 1990
Days to Decision 85 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
45d faster than avg
Panel avg: 130d · This submission: 85d
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 84
Devices cleared under the same product code (FGB) and FDA review panel - the closest regulatory comparables to K900813.
BARD URETEROSCOPE DEFLECTION MODULE
K920750 · C.R. Bard, Inc. · Apr 1992
PENTAX URETERORENOFIBERSCOPE, MODEL FUR-10P
K914106 · Pentax Precision Instrument Corp. · Jan 1992
BARD 3000 PLUS URETEROSCOPY SYSTEM
K911411 · C.R. Bard, Inc. · Apr 1991
CANDELA MINIFLEX DEFLECTABLE URETEROSCOPE
K884153 · Candela Laser Corp. · Dec 1988
BARD URETEROSCOPIC DEVICE
K883110 · C.R. Bard, Inc. · Oct 1988
OLYMPUS RIGID URETERORENOSCOPE
K852888 · Olympus Corp. · Aug 1985