510(k) · Cleared
ClearedTrocars,Cannulae,Sheaths,Obturators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Karl Storz Endoskop GmbH · ODB Endoscopic Contamination Prevention Sheath
Cleared on Sep 14, 1994 after a 47-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Sep 14, 1994
- Review
- 47 days
- Class
- Class II
- Product code
- ODB
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK943697 Trocars,Cannulae,Sheaths,ObturatorsKarl Storz Endoskop GmbH · 1994
- 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
Most influential descendants
Showing 5 of 5 · 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) | K943697 | Trocars,Cannulae,Sheaths,Obturators | Karl Storz Endoskop GmbH | 1994 | — |
| +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 |
| 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 ODB? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141272 | Floshield 10MM Endoscopic Cannula and Blunt Obturator, Floshield 10MM Endoscopic… | 2014 | 4 |
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 ODB devicesODB Endoscopic Contamination Prevention Sheath: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ODB
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · ODB
Too few ODB 510(k)s in any year since 2007 to give a median.
Recalls per year · ODB
No recall names ODB since 2007.
Adverse event reports per year · ODB
10in 2025
MAUDE reports naming product code ODB, 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 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 8 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 10 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K943697 · printed Nov 5, 2026
Cite this page
510(k) Report. “K943697: Trocars,Cannulae,Sheaths,Obturators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K943697
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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