# K030471: Ophtec Enclavation Needle

- Pathway: 510(k) (Traditional)
- Applicant: Ophtec, USA
- Decided: Apr 17, 2003 after 64 days
- Product code: HNQ (Hook, Ophthalmic)
- Device class: 1
- Regulation: 21 CFR 886.4350
- 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 K022842 (2002). 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)
- K022842: Stephens Disposable Hooks, Stephens Instruments (2002) Summary page 1.

## Indications for use
An OPHTEC Enclavation Needle is a hand held, non powered, single-use ophthalmic instrument used to manipulate iris tissue during the surgical procedure to fixate an ARTISANTM phakic or aphakic intraocular lens in a human eye.

Source page: https://510kreport.com/device/K030471
Methodology: https://510kreport.com/methodology