Cleared Traditional

CIRCULON SYSTEM STEP 2

K951021 · Convatec, A Division of E.R. Squibb & Sons · General & Plastic Surgery

Jun 1995

Decision

97d

Days

Class 2

Risk

About This 510(k) Submission

K951021 is an FDA 510(k) clearance for the CIRCULON SYSTEM STEP 2, a Wound Dressing Kit (Class II — Special Controls, product code MCY), submitted by Convatec, A Division of E.R. Squibb & Sons (Princeton, US). The FDA issued a Cleared decision on June 12, 1995, 97 days after receiving the submission on March 7, 1995. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.5075.

Submission Details

510(k) Number	K951021 FDA.gov
FDA Decision	Cleared SESK
Date Received	March 07, 1995
Decision Date	June 12, 1995
Days to Decision	97 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	MCY — Wound Dressing Kit
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5075
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.