# K061651: Fischer Cone Biopsy Excisor, Models 900-150, 151, 152, 154, 155, 157 and 158

- Pathway: 510(k) (Traditional)
- Applicant: Apple Medical Corp.
- Decided: Oct 20, 2006 after 129 days
- Product code: HGI (Electrocautery, Gynecologic (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.4120
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K070877: Endocervical Electrode # 2 (2007), 0 descendants of its own

## Recalls of this device
- May 25, 2022 · Class II · Z-1612-2022: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
- Mar 12, 2018 · Class II · Z-1879-2018: Products have been packaged with an incorrect product size.

## Indications for use
The Fischer Cone Biopsy device is indicated for Large Loop Excision Of The Transformation Zone (LLETZ) in the diagnosis and treatment of some cervical intraepithelial neoplasias (CIN) and dysplasias. The intended use is the same.

Source page: https://510kreport.com/device/K061651
Methodology: https://510kreport.com/methodology