Cleared Traditional

SINGLE CANNULA EXTENDED APPLICATOR

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

About This 510(k) Submission

K102563 is an FDA 510(k) clearance for the SINGLE CANNULA EXTENDED APPLICATOR, a Syringe, Irrigating (non Dental) (Class I — General Controls, product code KYZ), submitted by Micromedics, Inc. (St Paul, US). The FDA issued a Cleared decision on March 15, 2011, 189 days after receiving the submission on September 7, 2010. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6960.

Submission Details

510(k) Number K102563 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code KYZ — Syringe, Irrigating (non Dental)
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.6960