510(k) · Cleared
ClearedTorcars,Cannulae,Sheaths,Obturators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Karl Storz Endoskop GmbH · HET Laparoscope, Gynecologic (And Accessories)
Cleared on Jun 30, 1995 after a 333-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Jun 30, 1995
- Review
- 333 days
- Class
- Class II
- Product code
- HET
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK943713 Torcars,Cannulae,Sheaths,ObturatorsKarl Storz Endoskop GmbH · 1995
- Descendant · cites it directly · 4 of its ownK141272 Floshield 10MM Endoscopic Cannula and Blunt Obturator, Floshield…Minimmally Invasive Devices · 2014
- Descendant · 2 generations on · 3 of its ownK150705 FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator…Minimally Invasive Devices, Inc. · 2015
- Descendant · 3 generations on · 2 of its ownK241796 TroCare TroKit Laparoscope Lens Wiper (CP000626)TroCare, LLC · 2024
- Descendant · 4 generations on · 0 of its ownK253994 TroKit Laparoscope Lens WiperTroCare, LLC · 2026
- Descendant · 4 generations on · 0 of its ownK260089 TL-10 Laparoscopic Scope CleanerScopix, Ltd. · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K141272Floshield 10MM Endoscopic Cannula and Blunt Obturator, Floshield 10MM Endoscopic…Minimmally Invasive Devices · 2014 · cites it directly4descendants
- K150705FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator, FloShield 10mm Endoscopic…Minimally Invasive Devices, Inc. · 2015 · 2 generations on3descendants
- K241796TroCare TroKit Laparoscope Lens Wiper (CP000626)TroCare, LLC · 2024 · 3 generations on2descendants
- K253994TroKit Laparoscope Lens WiperTroCare, LLC · 2026 · 4 generations on0descendants
- K260089TL-10 Laparoscopic Scope CleanerScopix, Ltd. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K943713 | Torcars,Cannulae,Sheaths,Obturators | Karl Storz Endoskop GmbH | 1995 | — |
| +1 | K141272 | Floshield 10MM Endoscopic Cannula and Blunt Obturator, Floshield 10MM… | Minimmally Invasive Devices | 2014 | — |
| +2 | K150705 | FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator, FloShield 10mm… | Minimally Invasive Devices, Inc. | 2015 | — |
| +3 | K241796 | TroCare TroKit Laparoscope Lens Wiper (CP000626) | TroCare, LLC | 2024 | — |
| +4 | K253994 | TroKit Laparoscope Lens Wiper | TroCare, LLC | 2026 | — |
| +4 | K260089 | TL-10 Laparoscopic Scope Cleaner | Scopix, Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HET? 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 HET device
- #1 K250939 SIRIUS Endoscope System (PR-SI-1230)score 12.9 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K141272 (Minimmally Invasive Devices, 2014) has gone furthest, with 4 descendants of its own.
How does its category compare?
All HET devicesHET Laparoscope, Gynecologic (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HET
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HET
269in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HET
4in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HET
4,513in 2025
MAUDE reports naming product code HET, 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 | 181 |
| 2008 | 3 | 176 | 4 | 359 |
| 2009 | 1 | — | 1 | 403 |
| 2010 | 1 | — | 0 | 214 |
| 2011 | 2 | — | 0 | 417 |
| 2012 | 2 | — | 0 | 1,118 |
| 2013 | 2 | — | 0 | 1,035 |
| 2014 | 0 | — | 0 | 175 |
| 2015 | 2 | — | 1 | 124 |
| 2016 | 0 | — | 0 | 205 |
| 2017 | 2 | — | 0 | 89 |
| 2018 | 1 | — | 0 | 53 |
| 2019 | 2 | — | 0 | 44 |
| 2020 | 2 | — | 0 | 49 |
| 2021 | 4 | 269 | 0 | 132 |
| 2022 | 1 | — | 1 | 216 |
| 2023 | 0 | — | 4 | 824 |
| 2024 | 0 | — | 0 | 3,496 |
| 2025 | 2 | — | 0 | 4,513 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K943713 · printed Nov 6, 2026
Cite this page
510(k) Report. “K943713: Torcars,Cannulae,Sheaths,Obturators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K943713
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026