KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2)

The KARL STORZ Cysto-Urethro-Fiberscope (models 11272CU1 and 11272C2) is a flexible fiber endoscope used for visualization and operative access during diagnostic and therapeutic procedures of the urinary tract, including the urethra and bladder. It can operate standalone or connect to FDA-cleared camera heads and computer control units for image display.

The subject device is a flexible scope with a 2.33 mm working channel diameter, 370 mm working shaft length, 5.25 mm working shaft diameter, external light source, 0° viewing angle, 116° field of view, eyepiece viewer, and 210° up/140° down distal tip deflection. The main difference from the predicate (K945185) is a slightly larger working shaft diameter (5.25 mm vs. 5.07 mm) and slightly greater upward distal tip deflection (210° vs. 180°).

Biocompatibility testing per ISO 10993 series (Parts 2, 5, 10, 11, 12, 18, 23); reprocessing validation per ANSI/AAMI/ISO 14937, ANSI/AAMI ST98, ISO 17664-1, ISO 22441, and FDA reprocessing guidance; bench testing per IEC 60601-2-18, IEC 62471, ISO 8600-3, and ISO 8600-5 for mechanical, optical, photobiological, and thermal safety.

The device is substantially equivalent because it shares the same fundamental design (flexible endoscope), intended use (urinary tract visualization), and nearly identical technological characteristics as the predicate device. The minor dimensional differences (working shaft diameter increase and distal tip deflection enhancement) represent incremental improvements that do not alter the basic function or safety profile. Comprehensive bench testing—mechanical, optical, photobiological, and thermal—demonstrates performance equivalent to the predicate, and validated biocompatibility and reprocessing protocols confirm safety and effectiveness without requiring clinical data.