# K221893: KARL STORZ Bipolar Resectoscopes with HF Cable

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz Endoscopy America, Inc.
- Decided: Mar 17, 2023 after 261 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
Longest line of descent: 8 generations back to K911904 (1991). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210651: Resection Electrodes with HF cable, Olympus Winter & Ibe GmbH (2021) Summary page 6.

## Indications for use
The KARL STORZ bipolar resectoscopes with HF cable are intended for use by qualified surgeons for cutting, ablation, vaporization, and/or coagulation of tissue during various endoscopic urological procedures. The following models are intended for the aforementioned use: 27040AK, 27040AO, 27040BK, 27040BO, 27040BP, 27040SD, 27040SL, 27040SM, 27040XA, 27040XB, 27050CA, 27050CB, 27050SC, 27050SD, 27050SL, 27050SM, 27050XA, 27050XB, 27051PL, 27051XA, 27054CB, 27054SC, 27054SL, 27054XB, 27241AO, 27241BK, 27241BO, 27040BB, 27040OA, 27040OB, 27040OC, 27040OD, 27048BK, 27048CK, 27048CO, 27050AE, 27050AK, 27050BE, 27050BK, 27051A, 27051B, 27054CO, PV27051B, 27040DB, 27040EO, 27040EB, 27040BL1-S, 27040BLO1-S, 27040GD1-S, 27040GP1-S, 27040GP130-S, 27040GP140-S, 27040GPB1-S, 27040GPO1-S, 27040JB1-S, 27040JB130-S, 27040JBE130-S, 27040NB-S, 27040NBO-S, 27040VE-S. The KARL STORZ bipolar resectoscopes with HF cable are intended for use by qualified surgeons for cutting, ablation, vaporization, and/or coagulation of tissue during various endoscopic hysteroscopic electrosurgical procedures. The following models are intended for the aforementioned use: 26040SL, 26040XA, 26050CA, 26050SC, 26050SL, 26050XA, 26053CB, 26053SC, 26055CB, 26055LD, 26055SC, 26055SL, 26055XB, 26055XE, 26053OC, 26055CO, 26040OC, 26053EB, 26040EB, 26055EB, 26040BL1-S, 26040GP1-S, 26040JB1-S, 26040NB-S, 26055BL1 - S, 26055GP1 - S, 26055NB- S. The KARL STORZ bipolar resectoscopes with HF cable are intended for use by qualified surgeons for cutting, ablation, vaporization, and/or coagulation of tissue during various endoscopic urological and hysteroscopic electrosurgical procedures. The following models are intended for the aforementioned use: 011050-10, 011051-10, 011052-10, 011160-10, 011163-10, UH801.

Source page: https://510kreport.com/device/K221893
Methodology: https://510kreport.com/methodology