Cleared Traditional

K904826 - TKO TELESCOPING LITHOTOMY STIRRUP
(FDA 510(k) Clearance)

K904826 · D.L. Nelson and Assoc., Inc. · General & Plastic Surgery

Oct 1990

Decision

Days

Class 1

Risk

K904826 is an FDA 510(k) clearance for the TKO TELESCOPING LITHOTOMY STIRRUP. This device is classified as a Operating Room Accessories Table Tray (Class I — General Controls, product code FWZ).

Submitted by D.L. Nelson and Assoc., Inc. (Atlanta, US). The FDA issued a Cleared decision on October 31, 1990, 6 days after receiving the submission on October 25, 1990.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4950. 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..

Submission Details

510(k) Number	K904826 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 25, 1990
Decision Date	October 31, 1990
Days to Decision	6 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—

Device Classification

Product Code	FWZ — Operating Room Accessories Table Tray
Device Class	Class I — General Controls
CFR Regulation	21 CFR 878.4950
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.