# K943697: Trocars,Cannulae,Sheaths,Obturators

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz Endoskop GmbH
- Decided: Sep 14, 1994 after 47 days
- Product code: ODB (Endoscopic Contamination Prevention Sheath)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K141272: Floshield 10MM Endoscopic Cannula and Blunt Obturator, Floshield 10MM Endoscopic Cannula, Floshield 10MM Blunt Obturator (2014), 4 descendants of its own
- K150705: FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator, FloShield 10mm Endoscopic Cannula, FloShield 10mm Conical Blunt Obturator (2015), 3 descendants of its own
- K241796: TroCare TroKit Laparoscope Lens Wiper (CP000626) (2024), 2 descendants of its own
- K253994: TroKit Laparoscope Lens Wiper (2026), 0 descendants of its own
- K260089: TL-10 Laparoscopic Scope Cleaner (2026), 0 descendants of its own

Source page: https://510kreport.com/device/K943697
Methodology: https://510kreport.com/methodology