Cleared Traditional

K061646 - LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIES

K061646 is an FDA 510(k) clearance for LASERSCOPE GUIDED DELIVERY DEVICE (GDD)..., manufactured by Laserscope. The device is a Class 2 Gastroenterology & Urology device with product code FBO cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K061646 · Laserscope · Gastroenterology & Urology device
Download Printable Device Report (PDF)
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Jun 2006
Decision
15d
Days
Class 2
Risk

K061646 is an FDA 510(k) clearance for the LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIES. Classified as Cystourethroscope (product code FBO), Class II - Special Controls.

Submitted by Laserscope (San Jose, US). The FDA issued a Cleared decision on June 27, 2006 after a review of 15 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 Laserscope devices

FDA 510(k) Submission Details - K061646

510(k) Number K061646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2006
Decision Date June 27, 2006
Days to Decision 15 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 131d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

FBO Device Classification - Class 2, Special Controls

Product Code FBO Cystourethroscope
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 Consultant

Kema Quality B.V.
PATRICIA L MURPHY

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FBO Cystourethroscope

All 16
Devices cleared under the same product code (FBO) and FDA review panel - the closest regulatory comparables to K061646.
FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPE
K131364 · KARL STORZ Endoscopy-America, Inc. · Jan 2014
KARL STORZ PEDIATRIC FLEXIBLE CYSTO-URETHRO-FIBERSCOPE, MODEL 11278C1/ACUI AND CIRCON AUR-735 PEDIATRIC CYSTOURETHEROSCO
K082046 · KARL STORZ Endoscopy-America, Inc. · Oct 2008
KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEM
K062918 · KARL STORZ Endoscopy-America, Inc. · Jan 2007
CYSTO-URETHROSCOPES E-LINE EXISTING OF: SHEATHS, OBTURATORS, INSERTS, ATTCHEMENTS, AND FORCEPS MODEL 8650, 8652, 8660
K011496 · Richard Wolf Medical Instruments Corp. · Aug 2001
SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW SEMI0RIGID AND FLEXIBLE MANUAL SURGICAL INSTRUM
K972979 · Smith & Nephew, Inc. · Dec 1997
OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (UROLOGY)
K962474 · Olympus America, Inc. · Dec 1996

FDA 510(k) Resources - Gastroenterology & Urology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.