Cleared Special

E-Cath STIM acc. Tsui

K202699 · PAJUNK GmbH Medizintechnologie · Anesthesiology

Dec 2020

Decision

104d

Days

Class 2

Risk

About This 510(k) Submission

K202699 is an FDA 510(k) clearance for the E-Cath STIM acc. Tsui, 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 December 29, 2020, 104 days after receiving the submission on September 16, 2020. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5140.

Submission Details

510(k) Number	K202699 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 16, 2020
Decision Date	December 29, 2020
Days to Decision	104 days
Submission Type	Special
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.