# K894762: B100 Disposable Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Beacon Laboratories, Inc.
- Decided: Sep 15, 1989 after 50 days
- Product code: HAM (Apparatus, Electrosurgical)
- 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
No predicates in its family tree.
68 later devices descend from it; 1 cites it directly.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K963189: Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma Coagulator and Accessories (1996), 67 descendants of its own
- K013348: Modification to: Erbe Apc Connector Hose and Probes, Models 20132-158, 20132-155, 20132-156, 20132-157, 20132-166 (2001), 30 descendants of its own
- K024047: Erbe Vio Apc with Accessories (2003), 25 descendants of its own
- K030819: Plasmajet System (2004), 17 descendants of its own
- K090586: Bovie Icon GS Electrosurgical Generator (GS100), Handpiece (GS-OP-R), Reusable Handpiece Cable (GS807-RC) (2009), 16 descendants of its own

Source page: https://510kreport.com/device/K894762
Methodology: https://510kreport.com/methodology