Cleared Traditional

K962880 - SENSI-TOUCH COMBO SPINAL/EPIDURAL REGIONAL ANESTHESIA DELIVERY SYSTEM
(FDA 510(k) Clearance)

K962880 · Sherwood Medical Co. · Anesthesiology

Dec 1996

Decision

138d

Days

Class 2

Risk

K962880 is an FDA 510(k) clearance for the SENSI-TOUCH COMBO SPINAL/EPIDURAL REGIONAL ANESTHESIA DELIVERY SYSTEM, a Anesthesia Conduction Kit (Class II — Special Controls, product code CAZ), submitted by Sherwood Medical Co. (St. Louis, US). The FDA issued a Cleared decision on December 9, 1996, 138 days after receiving the submission on July 24, 1996. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5140.

Submission Details

510(k) Number	K962880 FDA.gov
FDA Decision	Cleared SESK
Date Received	July 24, 1996
Decision Date	December 09, 1996
Days to Decision	138 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement

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.