Cleared Traditional

K970873 - ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.) (FDA 510(k) Clearance)

Class I Ophthalmic device.

K970873 · American Medical Devices, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
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May 1997
Decision
71d
Days
Class 1
Risk

K970873 is an FDA 510(k) clearance for the ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.). Classified as Cannula, Ophthalmic (product code HMX), Class I - General Controls.

Submitted by American Medical Devices, Inc. (Atlanta, US). The FDA issued a Cleared decision on May 20, 1997 after a review of 71 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all American Medical Devices, Inc. devices

Submission Details

510(k) Number K970873 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1997
Decision Date May 20, 1997
Days to Decision 71 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 110d · This submission: 71d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.