# K993190: Advanced Computer Controlled Microkeratome-Accm, Model Surgical Instrument Systems (Sis)

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Instrument Systems (Sis), Ltd.
- Decided: Feb 10, 2000 after 140 days
- Product code: HNO (Keratome, Ac-Powered)
- Device class: 1
- Regulation: 21 CFR 886.4370
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K913697 (1991). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972808: Hansatome Microkeratome, Chiron Vision Corp. (1997) Summary page 1.
- K913697: Automatic Corneal Shaper, Hansa Research & Development, Inc. (1991) Summary page 1.

## Most influential descendants
- K053511: DA Vinci Femtosecond Surgical Laser (2006), 0 descendants of its own
- K043150: Amadeus II Epikeratome (2005), 0 descendants of its own

## Indications for use
The SIS, Ltd., ACCM microkeratome is a precision-manufactured instrument indicated for lamellar resection of the cornea.

Source page: https://510kreport.com/device/K993190
Methodology: https://510kreport.com/methodology