Cleared Abbreviated

K030179 - MEDISISS PHACOEMULSIFICATION TIPS/NEEDLES (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K030179 · Surgical Instruments Service and Savings, Inc. · Ophthalmic device
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Jan 2003
Decision
7d
Days
Class 2
Risk

K030179 is an FDA 510(k) clearance for the MEDISISS PHACOEMULSIFICATION TIPS/NEEDLES. Classified as Needle, Phacoemulsification, Reprocessed (product code NKX), Class II - Special Controls.

Submitted by Surgical Instruments Service and Savings, Inc. (Sisters, US). The FDA issued a Cleared decision on January 24, 2003 after a review of 7 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4670 - the FDA ophthalmic device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Surgical Instruments Service and Savings, Inc. devices

Submission Details

510(k) Number K030179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2003
Decision Date January 24, 2003
Days to Decision 7 days
Submission Type Abbreviated
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 110d · This submission: 7d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

Device Classification

Product Code NKX Needle, Phacoemulsification, Reprocessed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4670
Definition Needle For Phacoemulsification Device To Remove Cataractous Lens. Same As Needle For Main Phacoemulsification Device And Un-reprocessed Needle With Product Code Hqc, Except This Is A "reprocessed" Needle. The Phacoemulsification Device Is Not Reprocessed, Just The Needle. Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. (70 Fr 56911, Available At Https://www.govinfo.gov/content/pkg/fr-2005-09-29/pdf/05-19510.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.