# K950719: Oes Urology

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: Dec 11, 1996 after 664 days
- Product code: EZO (Urethrotome)
- Device class: 2
- Regulation: 21 CFR 876.4770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K790071 (1979). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K790071: Endoscope and Accessories, Olympus Corp. (1979) Summary page 1.
- K904940: Olympus Infant Resectoscope and Accessories, Olympus Corp. (1992) Summary page 1.
- K904939: Flexible and Rigid Ureterotome System, Olympus Corp. (1992). Our OCR of the scanned summary read K904339, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Olympus Flexible & Rigid Urethrotome System”.
- (no number) Karl Storz Endoscopes & Accessories for Urology: named in the summary without a submission number

## Indications for use
Olympus 00216 Otis Urethrotome and 02160 Replacement Blade are intended to be used for endoscopic and treatment within the urethra in adults. Olympus 02161 Otis Urethrotome and 02162 Replacement Blade are intended to be used for endoscopic treatment within the urethra in children.

Source page: https://510kreport.com/device/K950719
Methodology: https://510kreport.com/methodology