# K912265: Medilase Semi-Rigid Instrod Sheath Series AE1000

- Pathway: 510(k) (Traditional)
- Applicant: Medical Laser, Inc.
- Decided: Oct 10, 1991 after 141 days
- Product code: FED (Endoscopic Access Overtube, Gastroenterology-Urology)
- 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Source page: https://510kreport.com/device/K912265
Methodology: https://510kreport.com/methodology