R-Med Disposable Plug

FDA 510(k) K942411 · R-Med, Inc.

Substantially Equivalent

510(k) numberK942411

Submission

Device name
R-Med Disposable Plug
Applicant
R-Med, Inc.
Oregon, OH, US
Received
May 20, 1994
Decision date
March 31, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
HET – Laparoscope, Gynecologic (And Accessories)
Device class
Class II (moderate risk)
Regulation
21 CFR 884.1720
Specialty
Obstetrics/Gynecology

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More from 270surgical , Ltd.

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K001236Riza Band Stretcher (RBS)-60000FHN · Traditional 07/17/2000SE
K953360R-Med Abdominal Wall ElevatorHET · Traditional 01/11/1996SE
K954882Riza-Ribe Needle (Modification)HRX · Traditional 11/16/1995SE
K953441Riza-Ribe NeedleFBK · Traditional 08/18/1995SE
K950108R-Med Mini-RetractorHET · Traditional 05/11/1995SE
K945637R-Med Motorized Laparoscopic HandleGCJ · Traditional 12/07/1994SE
K943818Manual Laparosopic Handle, Interchangeable Laparoscopic Tool UnitsGEI · Traditional 08/29/1994SE
K935031Riza-Ribe NeedleHET · Traditional 04/25/1994SE

Questions and answers

When was R-Med Disposable Plug cleared by the FDA?

R-Med Disposable Plug (K942411) received a 510(k) decision of Substantially Equivalent on March 31, 1995, 315 days after the submission was received.

What is the product code of K942411?

The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.