510(k) · Cleared
ClearedDisposable and Reusable Ball and Loop Electrodes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
R-Group Intl. · HGI Electrocautery, Gynecologic (And Accessories)
Cleared on May 25, 2000 after a 199-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- May 25, 2000
- Review
- 199 days
- Class
- Class II
- Product code
- HGI
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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
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What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
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 loop electrodes are designed for the LEEP or LLETZ procedure, which is performed to remove a lesion of abnormal cells from the cervix. The loop electrode is aftached to an electrosurgical generator that emits an electrical current used to cut away the affected tissue, Following the removal of the cells in the affected area the ball electrode is used to seal the area and stop any bleeding that may have occurred. Some indications for use are: Cervical…
Read the full statement (111 words)
The loop electrodes are designed for the LEEP or LLETZ procedure, which is performed to remove a lesion of abnormal cells from the cervix. The loop electrode is aftached to an electrosurgical generator that emits an electrical current used to cut away the affected tissue, Following the removal of the cells in the affected area the ball electrode is used to seal the area and stop any bleeding that may have occurred.
Some indications for use are:
Cervical conizations
Large Loop Excision of the Transformation Zone
(LLETZ) in the Diagnosis and Treatment of some
Cetvical Intraepithelial Neoplasias (CIN) and
Dysplasias.
c. External Anogenital Lesions
d. Large Vaginal Intraepithelial Neoplasic (VAIN)
Lesions.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993777 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993777: Disposable and Reusable Ball and Loop Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993777
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026