# K961460: Lweet Cone Biopsy Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Apple Medical Corp.
- Decided: Nov 19, 1996 after 217 days
- Product code: HGI (Electrocautery, Gynecologic (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.4120
- 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Mar 10, 2006 · Not classified · Z-0616-06: Change in product material may be cause for wire breaking, and tip burning and melting during procedure. Broken pieces of the device may need to be retrieved from patient.
- Mar 10, 2006 · Not classified · Z-0617-06: Change in product material may be cause for wire breaking, and tip burning and melting during procedure. Broken pieces of the device may need to be retrieved from patient.
- Mar 10, 2006 · Not classified · Z-0615-06: Change in product material may be cause for wire breaking, and tip burning and melting during procedure. Broken pieces of the device may need to be retrieved from patient.
- Mar 10, 2006 · Not classified · Z-0614-06: Change in product material may be cause for wire breaking, and tip burning and melting during procedure. Broken pieces of the device may need to be retrieved from patient.
- Mar 10, 2006 · Not classified · Z-0618-06: Change in product material may be cause for wire breaking, and tip burning and melting during procedure. Broken pieces of the device may need to be retrieved from patient.
- Mar 10, 2006 · Not classified · Z-0619-06: Change in product material may be cause for wire breaking, and tip burning and melting during procedure. Broken pieces of the device may need to be retrieved from patient.
- Mar 10, 2006 · Not classified · Z-0620-06: Change in product material may be cause for wire breaking, and tip burning and melting during procedure. Broken pieces of the device may need to be retrieved from patient.
- Mar 10, 2006 · Not classified · Z-0621-06: Change in product material may be cause for wire breaking, and tip burning and melting during procedure. Broken pieces of the device may need to be retrieved from patient.

Source page: https://510kreport.com/device/K961460
Methodology: https://510kreport.com/methodology