# K210315: Single Use Hand Switch Monopolar Forceps with Smoke Evacuation, Single Use Hand Switch Bipolar Forceps with Smoke Evacuation, Single Use Hand Switch Monopolar Forceps, Single Use Hand Switch Bipolar Forceps

- Pathway: 510(k) (Traditional)
- Applicant: Modern Medical Equipment Manufacturing, Ltd.
- Decided: Mar 17, 2022 after 407 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- 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 K923332 (1992). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130669: Single Use & Multi Use Bipolar Forceps / Single Use & Multi Use Monopolar Forceps, Olsen Medical (2013) Summary page 4.
- K200372: Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical pencil, Modern Medical Equipment Manufacturing, Ltd. (2020) Summary page 5.
- K032327: Modern Medical Bipolar Forceps, Modern Medical Equipment Mfg., Ltd. (2004) Summary page 5.

## Indications for use
1. Single Use Hand Switch Monopolar Forceps with Smoke Evacuation (CD954) The device delivers electrosurgical current to target tissue for coagulation in electrosurgical procedure, with the additional function to facilitate the removal of surgical smoke generated by electrosurgery. 2. Single Use Hand Switch Bipolar Forceps with Smoke Evacuation (CD955) The device delivers electrosurgical current to target tissue for coagulation in electrosurgical procedure, with the additional function to facilitate the removal of surgical smoke generated by electrosurgery. 3. Single Use Hand Switch Monopolar Forceps (CD956) The device delivers electrosurgical current to target tissue for coagulation in electrosurgical procedure. 4. Single Use Hand Switch Bipolar Forceps (CD957) The device delivers electrosurgical current to target tissue for coagulation in electrosurgical procedure.

Source page: https://510kreport.com/device/K210315
Methodology: https://510kreport.com/methodology