Cleared Traditional

K970873 - ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.)

K970873 is an FDA 510(k) clearance for ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19..., manufactured by American Medical Devices, Inc.. The device is a Class 1 Ophthalmic device with product code HMX cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K970873 · American Medical Devices, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K970873

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 110d · This submission: 71d
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 57
Devices cleared under the same product code (HMX) and FDA review panel - the closest regulatory comparables to K970873.
WEISS RETINAL CANNULA
K010305 · Micron Surgical, Inc. · May 2001
VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES
K000457 · Retinalabs.Com · May 2000
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
K970873 · ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.)
Download PDF FDA Summary American Medical Devi…