# K981724: O.R.Pro 300 Electrosurgical Generator Model 40001-100

- Pathway: 510(k) (Traditional)
- Applicant: Medtrex, Inc.
- Decided: Jun 22, 1998 after 38 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: 1 generation back to K944602 (1995). 2 ancestors in all.
34 later devices descend from it; 1 cites it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944602: Valleylab Force FX, Valleylab, Inc. (1995) Summary page 2.
- K953007: Excalibur Plus Electrosurgical Unit, Aspen Laboratories, Inc. (1995) Summary page 2.

## Most influential descendants
- K073057: Pulsar Generator, Model PS100-100, and Peak Plasmablade Tissue Dissection Device, Model PS200-040 (2008), 33 descendants of its own
- K082786: Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection Devices (2008), 24 descendants of its own
- K093695: Peak Plasmablade 3.OS Tissue Dissection Device (2010), 8 descendants of its own
- K083415: Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection Device (2009), 8 descendants of its own
- K142410: Elliquence Electrodes (2015), 7 descendants of its own

## Indications for use
The O. R. Pro 300™ Electrosurgical Generator is a general purpose solid state generator used to supply the RF signals to electrosurgical handpieces used on soft tissues where a wide range of tissue types, patient conditions and load impedances are encountered.

Source page: https://510kreport.com/device/K981724
Methodology: https://510kreport.com/methodology