# K102029: Peak Pulsar II Generator Model PS100-102

- Pathway: 510(k) (Special)
- Applicant: Peak Surgical, Inc.
- Decided: Dec 16, 2010 after 150 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: 4 generations back to K933157 (1994). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082786: Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection Devices, Peak Surgical, Inc. (2008) Summary page 1.

## 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/K102029
Methodology: https://510kreport.com/methodology