Cleared Traditional

K895182 - ASI CYSTOSCOPE SHEATH

K895182 is an FDA 510(k) clearance for ASI CYSTOSCOPE SHEATH, manufactured by Advanced Surgical Intervention, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FAJ cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K895182 · Advanced Surgical Intervention, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Oct 1989
Decision
74d
Days
Class 2
Risk

K895182 is an FDA 510(k) clearance for the ASI CYSTOSCOPE SHEATH, GRASPING FORCEPS & FOR.BODY. Classified as Cystoscope And Accessories, Flexible/rigid (product code FAJ), Class II - Special Controls.

Submitted by Advanced Surgical Intervention, Inc. (San Clemente, US). The FDA issued a Cleared decision on October 24, 1989 after a review of 74 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 Advanced Surgical Intervention, Inc. devices

FDA 510(k) Submission Details - K895182

510(k) Number K895182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1989
Decision Date October 24, 1989
Days to Decision 74 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
56d faster than avg
Panel avg: 130d · This submission: 74d
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 63
Devices cleared under the same product code (FAJ) and FDA review panel - the closest regulatory comparables to K895182.
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
LASERSONICS LASER CYSTOSCOPE MODEL FCY-6-35
K860822 · Cooper Lasersonics, Inc. · Apr 1986
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