Cleared Traditional

K902274 - CUSTOMED CYSTO PACK I

K902274 is an FDA 510(k) clearance for CUSTOMED CYSTO PACK I, manufactured by Customed, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FAJ cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K902274 · Customed, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1990
Decision
122d
Days
Class 2
Risk

K902274 is an FDA 510(k) clearance for the CUSTOMED CYSTO PACK I. Classified as Cystoscope And Accessories, Flexible/rigid (product code FAJ), Class II - Special Controls.

Submitted by Customed, Inc. (Puerto Rico, US). The FDA issued a Cleared decision on September 20, 1990 after a review of 122 days - within the typical 510(k) review window.

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: 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 Customed, Inc. devices

FDA 510(k) Submission Details - K902274

510(k) Number K902274 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received May 21, 1990
Decision Date September 20, 1990
Days to Decision 122 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
8d faster than avg
Panel avg: 130d · This submission: 122d
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 64
Devices cleared under the same product code (FAJ) and FDA review panel - the closest regulatory comparables to K902274.
KARL STORZ FIXED MAGNIFICATION TELESCOPE/KARL STORZ VARIABLE MAGNIFICATION TELESCOPE
K935278 · KARL STORZ Endoscopy-America, Inc. · Jun 1994
BARD STABILIZING CANNULA
K930827 · C.R. Bard, Inc. · May 1993
PENTAX CYSTOFIBERSCOPE, MODEL FCY-15P
K914008 · Pentax Precision Instrument Corp. · Jan 1992
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