# K971853: Endoview Spphire Lens Set

- Pathway: 510(k) (Traditional)
- Applicant: American Medical Devices, Inc.
- Decided: Aug 6, 1997 after 78 days
- Product code: HJK (Lens, Contact, Polymethylmethacrylate, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 886.1385
- 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 K902496 (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)
- K902496: Landers Vitrectomy Lens Ring W/Infusion, Ocular Instruments, Inc. (1990) Summary page 2.
- (no number) DORC lens set: named in the summary without a submission number
- (no number) Grieshaber lens set: named in the summary without a submission number

## Indications for use
For magnification during vitreoretinal surgery.

Source page: https://510kreport.com/device/K971853
Methodology: https://510kreport.com/methodology