510(k) · Cleared
Recalled · Class II · 2022Fischer Cone Biopsy Excisor, Models 900-150, 151, 152, 154, 155, 157 and 158
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apple Medical Corp. · HGI Electrocautery, Gynecologic (And Accessories)
Cleared on Oct 20, 2006 after a 129-day review. The FDA summary names no predicate by number. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Oct 20, 2006
- Review
- 129 days
- Class
- Class II
- Product code
- HGI
- Recalls
- 2
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK061651 Fischer Cone Biopsy Excisor, Models 900-150, 151, 152, 154, 155, 157…Apple Medical Corp. · 2006
- Descendant · cites it directly · 0 of its ownK070877 Endocervical Electrode # 2Modern Medical Equipment Mfg., Ltd. · 2007
Most influential descendants
Showing 1 of 1 · See all- K070877Endocervical Electrode # 2Modern Medical Equipment Mfg., Ltd. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K061651 | Fischer Cone Biopsy Excisor, Models 900-150, 151, 152, 154, 155, 157 and 158 | Apple Medical Corp. | 2006 | — |
| +1 | K070877 | Endocervical Electrode # 2 | Modern Medical Equipment Mfg., Ltd. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HGI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HGI device
- #1 K202915 IRIS Thermocoagulator and Digital Colposcopescore 2.1 · 4 generations · no Class I recall
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070877 | Endocervical Electrode # 2 | 2007 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 25, 2022 | Class II | Z-1612-2022 | Environmental control | 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 | Under Investigation by firm | Products have been packaged with an incorrect product size. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K070877 (Modern Medical Equipment Mfg., Ltd., 2007) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HGI devicesHGI Electrocautery, Gynecologic (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HGI
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · HGI
Too few HGI 510(k)s in any year since 2007 to give a median.
Recalls per year · HGI
7in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HGI
41in 2025
MAUDE reports naming product code HGI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 1 | — | 1 | 0 |
| 2013 | 0 | — | 0 | 6 |
| 2014 | 1 | — | 1 | 1 |
| 2015 | 0 | — | 0 | 27 |
| 2016 | 1 | — | 0 | 56 |
| 2017 | 0 | — | 0 | 33 |
| 2018 | 0 | — | 0 | 30 |
| 2019 | 0 | — | 3 | 127 |
| 2020 | 0 | — | 0 | 102 |
| 2021 | 1 | — | 7 | 100 |
| 2022 | 0 | — | 0 | 104 |
| 2023 | 0 | — | 0 | 61 |
| 2024 | 0 | — | 0 | 44 |
| 2025 | 0 | — | 0 | 41 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061651 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061651: Fischer Cone Biopsy Excisor, Models 900-150, 151, 152, 154, 155, 157 and 158.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061651
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026