# K771189: Hot Temp Cautery

- Pathway: 510(k) (Traditional)
- Applicant: Edward Weck, Inc.
- Decided: Jul 11, 1977 after 10 days
- Product code: HQP (Unit, Cautery, Thermal, Battery-Powered)
- Device class: 2
- Regulation: 21 CFR 886.4115
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Jul 19, 2018 · Class II · Z-3045-2018: A small number of devices in this lot may have a melted cap and a hole formed through the packaging. The risk is potentially the product will no longer be sterile for use and may cause harm to a patie

Source page: https://510kreport.com/device/K771189
Methodology: https://510kreport.com/methodology