# K990872: Scleral Plugs, 19 and 20 Gauge

- Pathway: 510(k) (Traditional)
- Applicant: Ophthalmic Consultants, Inc.
- Decided: Jul 13, 1999 after 119 days
- Product code: LXP (Plug, Scleral)
- Device class: 2
- Regulation: 21 CFR 886.4155
- 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 K854507 (1986). 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)
- K854507: Storz MVS 19 & 20 Gauge Scleral Plugs, Storz Instrument Co. (1986) Summary page 1.

## Indications for use
The scleral plugs are provided as part of single- and multiple-use surgical component kits/packs, or as kit replacements, in order to maintain patency of a previously, made incision in the sclera of the eye, during ophthalmic surgical procedures, performed by a certified clinician in a clinical setting.

Source page: https://510kreport.com/device/K990872
Methodology: https://510kreport.com/methodology