Cleared Traditional

K033191 - SOHNIKS

K033191 is an FDA 510(k) clearance for SOHNIKS, manufactured by Sohniks Endoscopy, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FAJ cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K033191 · Sohniks Endoscopy, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
160d
Days
Class 2
Risk

K033191 is an FDA 510(k) clearance for the SOHNIKS. Classified as Cystoscope And Accessories, Flexible/rigid (product code FAJ), Class II - Special Controls.

Submitted by Sohniks Endoscopy, Inc. (Eagan, US). The FDA issued a Cleared decision on March 9, 2004 after a review of 160 days - an extended review 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: 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 Sohniks Endoscopy, Inc. devices

FDA 510(k) Submission Details - K033191

510(k) Number K033191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2003
Decision Date March 09, 2004
Days to Decision 160 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 131d · This submission: 160d
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 88
Devices cleared under the same product code (FAJ) and FDA review panel - the closest regulatory comparables to K033191.
NEOSCOPE - ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM
K042780 · Prosurg, Inc. · Feb 2005
ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565
K042225 · Acmi Corporation · Sep 2004
VISION-SCIENCES CST-2000 FLEXIBLE CYSTOSCOPE WITH SLIDE-ON ENDOSHEATH SYSTEM
K040215 · Vision-Sciences, Inc. · Apr 2004
ECN ELECTRONIC VIDEO CYSTONEPHROSCOPE
K030960 · Acmi Corporation · Jul 2003
ASAP CYSTOSCOPE
K031141 · Asap Endoscopic Products GmbH · Jun 2003
VISERA CYSTOVIDEOSCOPE OLYMPUS CYF TYPE V/VA
K021074 · Olympus America, Inc. · May 2002