Cleared Traditional

SUTURE REMOVAL KIT

K922339 · Transidyne General Corp. · General & Plastic Surgery

Dec 1992

Decision

206d

Days

Class 1

Risk

About This 510(k) Submission

K922339 is an FDA 510(k) clearance for the SUTURE REMOVAL KIT, a Suture Removal Kit (Class I — General Controls, product code MCZ), submitted by Transidyne General Corp. (Spartanburg, US). The FDA issued a Cleared decision on December 11, 1992, 206 days after receiving the submission on May 19, 1992. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number	K922339 FDA.gov
FDA Decision	Cleared SESK
Date Received	May 19, 1992
Decision Date	December 11, 1992
Days to Decision	206 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement

Device Classification

Product Code	MCZ — Suture Removal Kit
Device Class	Class I — General Controls
CFR Regulation	21 CFR 878.4800
Definition	This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm080217.pdf. 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.