Cleared Traditional

SONOLONG SONO, CURL SONO, NANOLINE, BRAND NAMES CARRYINGSONO/SONOLONG

K113188 · PAJUNK GmbH Medizintechnologie · Anesthesiology
Mar 2012
Decision
122d
Days
Class 2
Risk

About This 510(k) Submission

K113188 is an FDA 510(k) clearance for the SONOLONG SONO, CURL SONO, NANOLINE, BRAND NAMES CARRYINGSONO/SONOLONG, a Anesthesia Conduction Kit (Class II — Special Controls, product code CAZ), submitted by PAJUNK GmbH Medizintechnologie (Geisingen, DE). The FDA issued a Cleared decision on March 1, 2012, 122 days after receiving the submission on October 31, 2011. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5140.

Submission Details

510(k) Number K113188 FDA.gov
FDA Decision Cleared SESE
Date Received October 31, 2011
Decision Date March 01, 2012
Days to Decision 122 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CAZ — Anesthesia Conduction Kit
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5140
Definition This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.