Cleared Traditional

K102563 - SINGLE CANNULA EXTENDED APPLICATOR (FDA 510(k) Clearance)

Class I General Hospital device.

K102563 · Micromedics, Inc. · General Hospital
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Mar 2011
Decision
189d
Days
Class 1
Risk

K102563 is an FDA 510(k) clearance for the SINGLE CANNULA EXTENDED APPLICATOR. Classified as Syringe, Irrigating (non Dental) (product code KYZ), Class I - General Controls.

Submitted by Micromedics, Inc. (St. Paul, US). The FDA issued a Cleared decision on March 15, 2011 after a review of 189 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6960 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Micromedics, Inc. devices

Submission Details

510(k) Number K102563 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2010
Decision Date March 15, 2011
Days to Decision 189 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 128d · This submission: 189d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KYZ Syringe, Irrigating (non Dental)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6960
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.