Cleared Traditional

K010305 - WEISS RETINAL CANNULA

K010305 is an FDA 510(k) clearance for WEISS RETINAL CANNULA, manufactured by Micron Surgical, Inc.. The device is a Class 1 Ophthalmic device with product code HMX cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K010305 · Micron Surgical, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
90d
Days
Class 1
Risk

K010305 is an FDA 510(k) clearance for the WEISS RETINAL CANNULA. Classified as Cannula, Ophthalmic (product code HMX), Class I - General Controls.

Submitted by Micron Surgical, Inc. (Margate, US). The FDA issued a Cleared decision on May 2, 2001 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4350 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K010305

510(k) Number K010305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2001
Decision Date May 02, 2001
Days to Decision 90 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 110d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

HMX Device Classification - Class 1, General Controls

Product Code HMX Cannula, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4350
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HMX Cannula, Ophthalmic

All 76
Devices cleared under the same product code (HMX) and FDA review panel - the closest regulatory comparables to K010305.
VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES
K000457 · Retinalabs.Com · May 2000
ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.)
K970873 · American Medical Devices, Inc. · May 1997
STERISEAL OPHTHALMIC CANNULA
K943932 · Pharma-Plast, Ltd. · Jan 1995
INFUSION CANNULA
K942403 · Microsurgical Technology, Inc. · Aug 1994
INTER TIP T
K934844 · Microsurgical Technology, Inc. · Apr 1994
KIRWAN IRRIGATION/ASPIRATION HANDPIECE
K930113 · Kirwan Surgical Products, Inc. · Feb 1994
K010305 · WEISS RETINAL CANNULA
Download PDF FDA Summary Micron Surgical, Inc.