# K954050: Resectoscopes

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Nov 22, 1995 after 85 days
- Product code: FJL (Resectoscope)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K991563: Continuous Flow Hystero-Resectoscope, Knife Electrode, Spike Electrode, Vaporisation Electrode, Coagulation Electrode, C (1999), 6 descendants of its own
- K091465: Myosure Rod Lens Hysteroscope (2009), 4 descendants of its own
- K122563: Myosure XL Rod Lens Hysteroscope, Myosure XL Outlfow Channel (2012), 2 descendants of its own
- K182006: Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths (2018), 1 descendant of its own
- K050910: Roei Working Element and Roel Cutting Loops (2005), 1 descendant of its own

Source page: https://510kreport.com/device/K954050
Methodology: https://510kreport.com/methodology