510(k) Report

510(k) · Cleared

Cleared

Ophtec Enclavation Needle

K030471510(k) TraditionalCleared Apr 17, 200364-day reviewClass I21 CFR 886.4350

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ophtec, USA · HNQ Hook, Ophthalmic

Cleared on Apr 17, 2003 as substantially equivalent to K022842 (Stephens Instruments, 2002) after a 64-day review. Its family tree reaches back 1 generation to 2002.

Decided
Apr 17, 2003
Review
64 days
Class
Class I
Product code
HNQ
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K022842 (2002). No later device cites it as a predicate yet.

K022842 · Stephens Disposable Hooks · Stephens Instruments · 2002200020022004
K022842 · Stephens Disposable Hooks · Stephens Instruments · 20020
  1. Root · 1 generation backK022842 Stephens Disposable HooksStephens Instruments · 2002
  2. This deviceK030471 Ophtec Enclavation NeedleOphtec, USA · 2003
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K022842Stephens Disposable HooksStephens Instruments2002—
0 (this device)K030471Ophtec Enclavation NeedleOphtec, USA2003—
FIG. 1 — Lineage of K030471, 2002–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HNQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K022842Stephens Disposable Hooks
Summary page 1
…n Needle Common name: Enclavation Needle Classification name: 86HNQ, Ophthalmic Hook Substantially Equivalent to: Stephens Disposable Hooks (K022842) Description of Device: Enclavation Needles are surgical stainless steel needles that have been dulled and molded into a configu…
Stephens Instruments2002—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.

How does its category compare?

All HNQ devices

HNQ Hook, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HNQ

FDA has decided no HNQ device since 2007.

Median 510(k) review, days · HNQ

Too few HNQ 510(k)s in any year since 2007 to give a median.

Recalls per year · HNQ

1in 2024

2022: 12024: 1
2007high 1 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HNQ

11in 2025

2009: 12010: 22012: 12013: 22014: 12015: 32016: 22017: 42018: 152019: 92020: 52021: 42022: 52023: 22024: 162025: 11
2007high 16 (2024) · low 0 (2007)2025

MAUDE reports naming product code HNQ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—01
20100—02
20110—00
20120—01
20130—02
20140—01
20150—03
20160—02
20170—04
20180—015
20190—09
20200—05
20210—04
20220—15
20230—02
20240—116
20250—011
20260—0—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

Recent decisions in HNQ

The HNQ category page

  • K022842Stephens Disposable HooksStephens Instruments · 2002
  • K874991Prisma Disposable Irrigating Iris HookAdvanced Surgical Products, Inc. · 1988
  • K870440Look Lens LoopsLook, Inc. · 1987
  • K864292Disposal Surgical Instruments for OphthalmologyEye-Ko, Inc. · 1986
  • K863988Thorton Titanium Hook Angled RightKeeler Instruments, Inc. · 1986

https://510kreport.com/device/K030471 · printed Nov 3, 2026

Cite this page

510(k) Report. “K030471: Ophtec Enclavation Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030471

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026