# K111262: Electrosurgical Monopolar Cable/Adapters, Electrosurgical Bipolar Cable/ Adapters, Bipolar Electrosurgical Cables, Monop

- Pathway: 510(k) (Traditional)
- Applicant: Olsen Medical
- Decided: May 23, 2012 after 384 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K991218 (1999). 18 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941908: Quantum Mono-Polar Electrosurgical Cable, Quantum Instruments Corp. (1994) Summary page 2.
- K942194: Quantum BI-Polar Electrosurgical Cable, Quantum Instruments Corp. (1994) Summary page 2.
- K073450: Sutter Electrosurgical Cables, Sutter Medizintechnik GmbH (2008) Summary page 2.
- K083528: Smith & Nephew Bipolar Adapter Cable, Model 72200022, Smith & Nephew, Inc. (2009) Summary page 2.

## Cited in the summary but kept off the family tree
- K982667: Micromedics Nasal Septal Button, Micromedics, Inc. (1998). Our reading of the summary gave K982667, FDA’s number for Micromedics Nasal Septal Button (Micromedics, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Richard Wolf Medical Instruments”. Kept off the family tree. Summary page 2.

## Most influential descendants
- K241621: Da Vinci Monopolar and Bipolar Adapters (378896) (2024), 0 descendants of its own
- K143662: Bissinger Monopolar Forceps and Cables (2015), 0 descendants of its own
- K133167: Monopolar Cautery Cord, Bipolar Cautery Cord (2014), 0 descendants of its own

## Recalls of this device
- May 11, 2018 · Class II · Z-1942-2018: Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.
- May 11, 2018 · Class II · Z-1943-2018: Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.

## Indications for use
The Olsen Medical Electrosurgical Cables/Adapters are intended for connecting monopolar/bipolar electrosurgical instruments to an electrosurgical generator to provide transmission of high frequency current from the electrosurgical generator to the surgical instrument.

Source page: https://510kreport.com/device/K111262
Methodology: https://510kreport.com/methodology