Cleared Traditional

K960872 - CYSTOSCOPE 0/15/30/70 DEGREES

K960872 is an FDA 510(k) clearance for CYSTOSCOPE 0/15/30/70 DEGREES, manufactured by Pollux Endoscopy, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FAJ cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K960872 · Pollux Endoscopy, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
64d
Days
Class 2
Risk

K960872 is an FDA 510(k) clearance for the CYSTOSCOPE 0/15/30/70 DEGREES. Classified as Cystoscope And Accessories, Flexible/rigid (product code FAJ), Class II - Special Controls.

Submitted by Pollux Endoscopy, Inc. (Sunrise, US). The FDA issued a Cleared decision on May 7, 1996 after a review of 64 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 Pollux Endoscopy, Inc. devices

FDA 510(k) Submission Details - K960872

510(k) Number K960872 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1996
Decision Date May 07, 1996
Days to Decision 64 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
67d faster than avg
Panel avg: 131d · This submission: 64d
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 79
Devices cleared under the same product code (FAJ) and FDA review panel - the closest regulatory comparables to K960872.
NTECH CYSTOSCOPES
K980592 · N-Tech Endoscopy, Inc. · Apr 1998
FIEGERT ENDOTECH CYSTOSCOPE
K970892 · Fiegert, Inc. · May 1997
FLEXIBLE CYSTOSCOPE
K964037 · Applied Fiberoptics, Inc. · Feb 1997
IMAGYN UROSCOPE
K953201 · Imagyn Medical, Inc. · Aug 1995
KARL STORZ TELESCOPE BRIDGES AND ADAPTERS
K945527 · KARL STORZ Endoscopy-America, Inc. · Dec 1994
KARL STORZ HOPKINS I&II/OPER/AUTOCLAVABLE TELESCOPESQ
K943176 · KARL STORZ Endoscopy-America, Inc. · Dec 1994