Microflex

FDA 510(k) K942304 · Moeller Microsurgical, Inc.

Substantially Equivalent

510(k) numberK942304

Submission

Device name
Microflex
Applicant
Moeller Microsurgical, Inc.
Waldwick, NJ, US
Received
May 13, 1994
Decision date
June 13, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FSO – Microscope, Surgical, General & Plastic Surgery
Device class
Class I (low risk)
Regulation
21 CFR 878.4700
Specialty
General, Plastic Surgery

Other 510(k)s with product code FSO

510(k)DeviceApplicantDecision
K941399Operating Microscope Aa Om 10FSO · Traditional Appasamy Associates (U.S.A.), Inc.04/22/1994SE
K920689Deemed MSS -- Microscope Support SystemFSO · Traditional Deemed, Inc.11/12/1993SE
K926288Som 6VI (Surgical Operating Microscope)FSO · Traditional Jedmed Instrument Co.10/12/1993SE
K931303Woodlyn Operation MicroscopeFSO · Traditional Woodlyn, Inc.06/25/1993SE
K926513Moller-Wedel Operating MicroscopeFSO · Traditional Moeller Microsurgical, Inc.06/22/1993SE
K910357Som 6VFSO · Traditional Jedmed Instrument Co.02/19/1991SE
K902076J2 MicroscopeFSO · Traditional Jedmed Instrument Co.08/01/1990SE
K874241Opmi MD Surgical MicroscopeFSO · Traditional Carl Zeiss, Inc.12/23/1987SE
K822562Odonto-ScopeFSO · Traditional Treace Medical, Inc.10/06/1982SE
K822181Binocular Oper. Microscopes & AccessorFSO · Traditional Kelleher Corp.08/27/1982SE

More from Kelleher Corp.

510(k)DeviceDecision
K926513Moller-Wedel Operating MicroscopeFSO · Traditional 06/22/1993SE

Questions and answers

When was Microflex cleared by the FDA?

Microflex (K942304) received a 510(k) decision of Substantially Equivalent on June 13, 1994, 31 days after the submission was received.

What is the product code of K942304?

The FDA product code is FSO – Microscope, Surgical, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4700.