Els Automatic Tubing Clamp System

FDA 510(k) K921993 · Rocky Mountain Research, Inc.

Substantially Equivalent

510(k) numberK921993

Submission

Device name
Els Automatic Tubing Clamp System
Applicant
Rocky Mountain Research, Inc.
Salt Lake City, UT, US
Received
April 28, 1992
Decision date
January 5, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
FIG – Clamp, Tubing, Blood, Automatic
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5820
Specialty
Gastroenterology, Urology
Life-sustaining
Yes

Other 510(k)s with product code FIG

510(k)DeviceApplicantDecision
K093915Deka Tac DeviceFIG · Traditional Deka Research & Development Corp.08/23/2011SE
K914459Automatic Tubing ClampFIG · Traditional Rocky Mountain Research, Inc.06/24/1992SE
K770535C-Dak 3500FIG · Traditional Cordis Corp.04/15/1977SE

More from Cordis Corp.

510(k)DeviceDecision
K992857Levelsens - Flexible, Model 201110, Levelsens - Rigid, Model 201070DTW · Traditional 11/10/1999SE
K961364Automatic Tubing Clamp System (Atc)KRL · Traditional 10/31/1996SE
K961598Els Automatic Tubing Clamp SystemKRL · Traditional 10/29/1996SE
K914459Automatic Tubing ClampFIG · Traditional 06/24/1992SE

Questions and answers

When was Els Automatic Tubing Clamp System cleared by the FDA?

Els Automatic Tubing Clamp System (K921993) received a 510(k) decision of Substantially Equivalent on January 5, 1994, 617 days after the submission was received.

What is the product code of K921993?

The FDA product code is FIG – Clamp, Tubing, Blood, Automatic, a Class II (moderate risk) device regulated under 21 CFR 876.5820.