Gyrus Acmi L P

FDA Filings

This page includes the latest FDA filings for Gyrus Acmi L P. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

Registration Number	3005975494
FEI Number	3011050570
Name	GYRUS ACMI L.P.
Owner & Operator	Olympus Medical Systems Corporation
Contact Address	2951 Ishikawa-cho Hachioji-shi JP-13 Tokyo 192-8507 JP
Registration Status	1
Initial Importer	Y
Registration Expiration	2020-04-25
Registration Address	9600 Louisiana Avenue North Brooklyn Park, MN 55445 US
Establishment Type	Repack or Relabel Medical Device

FDA Filings

Device Company	Device	Date
PMN K945262 \| FAJ GYRUS ACMI L.P. [Olympus Medical Systems Corporation]	Telescopes - autoclavable	2014-01-31
PMN K941952 \| FAD GYRUS ACMI L.P. [Olympus Medical Systems Corporation]	E-Z infuser Set	2012-11-02
PMN K980366 \| GEI GYRUS ACMI L.P. [Olympus Medical Systems Corporation]	Bovie Accessories	2012-10-22
PMN K022543 \| FNS GYRUS ACMI L.P. [Olympus Medical Systems Corporation]	VISTA	2012-10-22
PMN K022543 \| FAS GYRUS ACMI L.P. [Olympus Medical Systems Corporation]	VISTA	2012-10-22
NWW GYRUS ACMI L.P. [Olympus Medical Systems Corporation]	Grasper forceps	2012-10-22
NWW GYRUS ACMI L.P. [Olympus Medical Systems Corporation]	Cannula	2012-10-22
NWW GYRUS ACMI L.P. [Olympus Medical Systems Corporation]	Biopsy forceps	2012-10-22
NWW GYRUS ACMI L.P. [Olympus Medical Systems Corporation]	Alligator forceps	2012-10-22
PMN K081766 GYRUS-ACMI L.P.	PKS OMNI INSTRUMENT	2008-08-08
FCW GYRUS ACMI L.P. [Olympus Medical Systems Corporation]	AIL-220 Light Source	2008-03-05

Similar & Related FDA Registered Companies

Gyrus ACMI, Inc.6675 185th Avenue Neredmond, WA 98052 PMA NumberP180007 Supplement NumberS009 Date Received04/12/2022 Decision Date05/12/2022 Product Code NJK Advisory Committee Anesthesiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

Related Finance Registrations

NCAGE Code	04264	GYRUS ACMI L.P.
NCAGE Code	4TDD3	GYRUS ACMI L.P.
NCAGE Code	02033	GYRUS ACMI L.P.!DBA CIRCON-ACMI DIV
NCAGE Code	63390	GYRUS ACMI L.P.!DBA CIRCON SURGITEK
CAGE Code	02033	GYRUS ACMI L.P. CIRCON-ACMI DIV
CAGE Code	04264	GYRUS ACMI L.P.
CAGE Code	4TDD3	GYRUS ACMI L.P.
CAGE Code	63390	GYRUS ACMI L.P. CIRCON SURGITEK