# K914910: Davol Laparoscopic Instruments (Gen Surg Reusable)

- Pathway: 510(k) (Traditional)
- Applicant: Davol, Inc.
- Decided: Jan 6, 1992 after 66 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 8 (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
- Jan 9, 2024 · Class II · Z-1893-2025: Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.
- Jan 9, 2024 · Class II · Z-1894-2025: Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.
- Jan 9, 2024 · Class II · Z-1895-2025: Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.
- Jan 9, 2024 · Class II · Z-1896-2025: Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.
- Jan 9, 2024 · Class II · Z-1900-2025: Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.
- Jan 9, 2024 · Class II · Z-1899-2025: Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.
- Jan 9, 2024 · Class II · Z-1898-2025: Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.
- Jan 9, 2024 · Class II · Z-1897-2025: Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.

Source page: https://510kreport.com/device/K914910
Methodology: https://510kreport.com/methodology