# K082786: Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection Devices

- Pathway: 510(k) (Traditional)
- Applicant: Peak Surgical, Inc.
- Decided: Dec 3, 2008 after 71 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K933157 (1994). 19 ancestors in all.
24 later devices descend from it; 7 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073057: Pulsar Generator, Model PS100-100, and Peak Plasmablade Tissue Dissection Device, Model PS200-040, Peak Surgical, Inc. (2008) Summary page 1.
- K061174: Surgi-Max, Ellman Int'L, Inc. (2006) Summary page 1.
- K073616: Fas-Clean Electrosurgical Coated Active Blade, Electromedics Co., Ltd. (2008) Summary page 1.

## Most influential descendants
- K093695: Peak Plasmablade 3.OS Tissue Dissection Device (2010), 8 descendants of its own
- K142410: Elliquence Electrodes (2015), 7 descendants of its own
- K160041: Cobbra RF Tissue Dissector (2016), 6 descendants of its own
- K183611: Soniquence RF Generator and Soniquence Electrodes (2019), 5 descendants of its own
- K121881: Domain Surgical System (2012), 4 descendants of its own

## Recalls of this device
- May 19, 2009 · Not classified · Z-1022-2011: A customer reported that a patient suffered a burn while using the device.

## Indications for use
The PEAK Surgery System is indicated for cutting and coagulation of soft tissue during General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal and Neurological surgical procedures.

Source page: https://510kreport.com/device/K082786
Methodology: https://510kreport.com/methodology