Cleared Traditional

K860822 - LASERSONICS LASER CYSTOSCOPE MODEL FCY-6-35

K860822 is an FDA 510(k) clearance for LASERSONICS LASER CYSTOSCOPE MODEL FCY-6-35, manufactured by Cooper Lasersonics, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FAJ cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K860822 · Cooper Lasersonics, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1986
Decision
44d
Days
Class 2
Risk

K860822 is an FDA 510(k) clearance for the LASERSONICS LASER CYSTOSCOPE MODEL FCY-6-35. Classified as Cystoscope And Accessories, Flexible/rigid (product code FAJ), Class II - Special Controls.

Submitted by Cooper Lasersonics, Inc. (Santa Clara, US). The FDA issued a Cleared decision on April 17, 1986 after a review of 44 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 Cooper Lasersonics, Inc. devices

FDA 510(k) Submission Details - K860822

510(k) Number K860822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1986
Decision Date April 17, 1986
Days to Decision 44 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
86d faster than avg
Panel avg: 130d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FAJ Device Classification - Class 2, Special Controls

Product Code FAJ Cystoscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine And Perform 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 - FAJ Cystoscope And Accessories, Flexible/rigid

All 62
Devices cleared under the same product code (FAJ) and FDA review panel - the closest regulatory comparables to K860822.
BARD STABILIZING CANNULA
K930827 · C.R. Bard, Inc. · May 1993
PENTAX CYSTOFIBERSCOPE, MODEL FCY-15P
K914008 · Pentax Precision Instrument Corp. · Jan 1992
CUSTOMED CYSTO PACK I
K902274 · Customed, Inc. · Sep 1990
CURITY ECONOMY II CYSTOSCOPY TRAY
K820851 · The Kendal Co. · May 1982
SHEATH, CYSTOURETHROSCOPE W/ OBTURATOR
K760179 · V. Mueller O.V. Baxter Healthcare Corp. · Dec 1976
STOPCOCK, WATERLINE
K760189 · V. Mueller O.V. Baxter Healthcare Corp. · Dec 1976