# K970878: Endolight Fiberoptic Regular Monofilament and Fine Monofilament

- Pathway: 510(k) (Traditional)
- Applicant: American Medical Devices, Inc.
- Decided: May 6, 1997 after 57 days
- Product code: MPA (Endoilluminator)
- 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. The FDA summary names its predicate without a number.
- (no number) Gamp & Assoc.: named in the summary without a submission number
- (no number) Grieshaber: named in the summary without a submission number

## Indications for use
For illumination during surgery. Regular Monofilament — Inserts into any standard Fiberoptic Pic Set. Fine Monofilament — Inserts into any standard Fiberoptic Forceps.

Source page: https://510kreport.com/device/K970878
Methodology: https://510kreport.com/methodology