510(k) · Cleared
ClearedVersapoint II Bipolar Electrosurgery Generator, Versapoint II 44MM Angled Loop Electrode, Versapoint II Footswitch, Vers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ETHICON, Inc. · HIN Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)
Cleared on Dec 2, 2011 as substantially equivalent to K962482 (Gynecare, Inc., 1996) and 1 other predicate after a 163-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it.
- Decided
- Dec 2, 2011
- Review
- 163 days
- Class
- Class II
- Product code
- HIN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K962482 (1996). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K122983Ksea Bipolar ElectrodeKARL STORZ Endoscopy-America, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K962482 | Scuba System | Gynecare, Inc. | 1996 | 1 |
| 0 (this device) | K111751 | Versapoint II Bipolar Electrosurgery Generator, Versapoint II 44MM Angled Loop… | ETHICON, Inc. | 2011 | — |
| +1 | K122983 | Ksea Bipolar Electrode | KARL STORZ Endoscopy-America, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 HIN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K962482 | Scuba SystemSummary page 1…Regulatory Class: Class 11 Product Code: HIH Predicate 0 GYNECARE VERSAPOINT Bipolar Electrocautery System (K962482) Devices * VERSAPOINT VRS 2.5mm Angled Loop Electrode (K9944 18) Description of The GYNECARE VERSAPOINTTM 11 Bipola… | 1996 |
| * | K994418 | Versapoint Electrosurgery System (Scuba)Summary page 1…Product Code: HIH Predicate 0 GYNECARE VERSAPOINT Bipolar Electrocautery System (K962482) Devices * VERSAPOINT VRS 2.5mm Angled Loop Electrode (K9944 18) Description of The GYNECARE VERSAPOINTTM 11 Bipolar Electrosurgery System the Device (VERSAPOINT 11 System) is the ne… | 2000 |
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 |
|---|---|---|---|
| K122983 | Ksea Bipolar Electrode | 2013 | 0 |
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.
What does this lineage say?
How does its category compare?
All HIN devicesHIN Coagulator-Cutter, Endoscopic, Bipolar (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · HIN
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · HIN
Too few HIN 510(k)s in any year since 2007 to give a median.
Recalls per year · HIN
No recall names HIN since 2007.
Adverse event reports per year · HIN
43in 2025
MAUDE reports naming product code HIN, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 6 |
| 2010 | 0 | — | 0 | 7 |
| 2011 | 2 | — | 0 | 6 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 2 | — | 0 | 14 |
| 2014 | 1 | — | 0 | 12 |
| 2015 | 0 | — | 0 | 8 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 8 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 9 |
| 2021 | 0 | — | 0 | 10 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 29 |
| 2025 | 0 | — | 0 | 43 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The GYNECARE VERSAPOINTTM 11 Bipolar Electrosurgery System is intended for use in tissue cutting, removal and desiccation as requited or encountered in gynecologic hysteroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions, and septa, and benign conditions requiting endometrial ablation. Procedures include:
* Excision of intrauterine myomas
* Excision of intrauterine polyps
* Lysis of intrauterine adhesions
* Incision of uterine septa
* Endometrial ablation
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111751 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111751: Versapoint II Bipolar Electrosurgery Generator, Versapoint II 44MM Angled Loop Electrode, Versapoint II Footswitch, Vers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111751
Report an extraction error
Are you the manufacturer?
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