510(k) · Cleared
ClearedKsea Bipolar Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KARL STORZ Endoscopy-America, Inc. · HIN Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)
Cleared on Jun 26, 2013 as substantially equivalent to K061541 (Ksea, 2006) and 1 other predicate after a 273-day review. Its family tree reaches back 2 generations to 1996.
- Decided
- Jun 26, 2013
- Review
- 273 days
- Class
- Class II
- Product code
- HIN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K962482 (1996). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K962482 | Scuba System | Gynecare, Inc. | 1996 | 1 |
| −1 | K111751 | Versapoint II Bipolar Electrosurgery Generator, Versapoint II 44MM Angled Loop… | ETHICON, Inc. | 2011 | — |
| 0 (this device) | 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 |
| 2006 | 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 |
|---|---|---|---|
| * | K061541 | Ksea Bipolar ElectrotomeSummary page 3…3 === K122983 Page 3 of 4 STORZ KARL STORZ — ENDOSKOPE Predicate Devices: The KSEA Bipolar Electrode is substantially equivalent to the predicate Bipolar Electrotome (K061541) and GYNECARE VERSAPOINT Bipolar Electrosurgery System (K111751) Bipolar Electrotome The subject KSEA Electrode is substantiall… | 2006 |
| * | K111751 | Versapoint II Bipolar Electrosurgery Generator, Versapoint II 44MM Angled Loop…Summary page 3…ate Devices: The KSEA Bipolar Electrode is substantially equivalent to the predicate Bipolar Electrotome (K061541) and GYNECARE VERSAPOINT Bipolar Electrosurgery System (K111751) Bipolar Electrotome The subject KSEA Electrode is substantially equivalent to Bipolar Electrotome (K061541) with the same feat… | 2011 |
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.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 15.1 years on median.
- 1 of the 4 ancestors has a recall of any class.
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. 2013, 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 Karl Storz Bipolar Electrode is intended for use in tissue cutting, removal and desiccation as required or encountered in gynecologic hysteroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions and septa, and benign conditions requiring endometrial ablation. Procedures include:
Excision of intrauterine myomas
Excisfon of intrauterine polyps
Lysis of intrauterine adhesions
Incision of uterine septa
Endometrial ablation
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K122983 · printed Nov 4, 2026
Cite this page
510(k) Report. “K122983: Ksea Bipolar Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K122983
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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