Cleared Traditional

K102563 - SINGLE CANNULA EXTENDED APPLICATOR

K102563 is an FDA 510(k) clearance for SINGLE CANNULA EXTENDED APPLICATOR, manufactured by Micromedics, Inc.. The device is a Class 1 General Hospital device with product code KYZ cleared through the Traditional 510(k) pathway after a 189-day FDA review.

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

FDA 510(k) Submission Details - K102563

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 129d · This submission: 189d
Pathway characteristics
Predicate-based equivalence.

KYZ Device Classification - Class 1, General Controls

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.

Regulatory Peers - KYZ Syringe, Irrigating (non Dental)

All 24
Devices cleared under the same product code (KYZ) and FDA review panel - the closest regulatory comparables to K102563.
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