# K963088: Sheath, Electrosurgical Pencil

- Pathway: 510(k) (Traditional)
- Applicant: Aspen Laboratories, Inc.
- Decided: Sep 13, 1996 after 36 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K992149: Geiger Electrosurgical Handpiece Sheath, Model 405 (1999), 1 descendant of its own
- K011929: Handpiece Sheath-Model #A910 (2001), 0 descendants of its own

## Recalls of this device
- Feb 28, 2017 · Class II · Z-1758-2017: For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were labeled as St
- Feb 28, 2017 · Class II · Z-1757-2017: For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were labeled as St
- Feb 28, 2017 · Class II · Z-1759-2017: For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were labeled as St
- Feb 28, 2017 · Class II · Z-1756-2017: For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were labeled as St
- Feb 28, 2017 · Class II · Z-1760-2017: For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were labeled as St

Source page: https://510kreport.com/device/K963088
Methodology: https://510kreport.com/methodology