# K800617: Hyfrecator, #733

- Pathway: 510(k) (Traditional)
- Applicant: Birtcher Corp.
- Decided: May 2, 1980 after 45 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1,325 later devices descend from it; 5 cite it directly.
0 of 1,326 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
- K964849: Arthrocare Dermatologic Electrosurgery System (1997), 1,322 descendants of its own
- K973478: Arthrocare Sinus Electrosurgery System (1998), 1,219 descendants of its own
- K981870: Visage Cosmetic Surgery System (1998), 1,073 descendants of its own
- K000944: Thermage Thermacool System (2000), 1,069 descendants of its own
- K971532: Arthrocare Electrosurgery System (1997), 1,029 descendants of its own

## Recalls of this device
- Jan 28, 2013 · Class II · Z-0826-2013: Some devices had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products.
- Jan 28, 2013 · Class II · Z-0827-2013: Some devices had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products.
- Dec 27, 2012 · Class II · Z-0718-2013: ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no insta
- Dec 27, 2012 · Class II · Z-0719-2013: ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no insta

Source page: https://510kreport.com/device/K800617
Methodology: https://510kreport.com/methodology