# K031758: Acmi M4 Telescopes

- Pathway: 510(k) (Traditional)
- Applicant: Acmi Corporation
- Decided: Sep 2, 2003 after 88 days
- Product code: FBP (Telescope, Rigid, Endoscopic)
- 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
Longest line of descent: 1 generation back to K890328 (1990). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K890328: Adult Resectoscope, Circon Video (1990) Summary page 1.

## Indications for use
ACMI M4TMSeries Telescopes are intended for use in patients requiring endoscopic evaluation or for surgical procedures of the urological or gynecological systems.

Source page: https://510kreport.com/device/K031758
Methodology: https://510kreport.com/methodology