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Gyrus Acmi, Inc.

United States·US-MF-000034237

Last updated September 17, 2026

Information

Country: United States
Address: 9600, Louisiana Ave. North, , Brooklyn Park, MN, United States
Website: olympus-osta.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Dave Joppru
EUDAMED SRN: US-MF-000034237
FDA FEI Number: 3003790304
DUNS Number: —

Catalogue (2823)

Page 57 of 57

Device	Model / Reference	Registries	Class	Status
ChitoZolve	K181696	FDA 510(k)	Class I	Active
POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)	K252487	FDA 510(k)	Class II	Active
Gyrus Acmi Telescope Storage-Sterilization Tray	K120474	FDA 510(k)	Class II	Active
PK Spatula	K142289	FDA 510(k)	Class II	Active
Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4	K092278	FDA 510(k)	Class II	Active
POWERSEAL Sealer and Divider	K231327	FDA 510(k)	Class II	Active
Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter	K180086	FDA 510(k)	Class II	Active
Olympus Energy Power System (eps)	K123429	FDA 510(k)	Class II	Active
Pk Needle	K142154	FDA 510(k)	Class II	Active
Dolphin 3 Fluid Management System	K110852	FDA 510(k)	Class II	Active
Gyrus Acmi Cyber Wand-Sterilization Trays Model Fgt	K102970	FDA 510(k)	Class II	Active
Gyrus Acmi Nephro - Ezdilate Nephrostomy Balloon Dilation Catheter	K132383	FDA 510(k)	U	Active
Gyrus Acmi Ipn-2505, Invisio Smith Percutaneous Nephroscope System	K072594	FDA 510(k)	Class II	Active
Pk Aim	K163373	FDA 510(k)	Class II	Active
Berkeley VC-10 Vacuum Curettage System	K171440	FDA 510(k)	Class II	Active
PK Cutting Forceps for ESG-400 Workstation	K142759	FDA 510(k)	Class II	Active
InstaClear Lens Cleaner	K152531	FDA 510(k)	Class II	Active
Pk J-Hook	K142350	FDA 510(k)	Class II	Active
SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories	K221306	FDA 510(k)	Class II	Active
G3 Generator And Accessories-Dissector Plasma Knife	K080844	FDA 510(k)	Class II	Active
Gyrus Acmi Halo Pks Cutting Forceps	K100896	FDA 510(k)	Class II	Active
Spiration Valve System Deployment Catheter and Loader	P180007	FDA PMA	Class III	Active
Falope-Ring (r) Band Contraceptive Tubal Occlusion System	P870076	FDA PMA	Class III	Active

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FDA Recalls (24)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Mar 8, 2019	Z-1183-2019	—	terminated	Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
Mar 8, 2019	Z-1180-2019	—	terminated	Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
Mar 8, 2019	Z-1182-2019	—	terminated	Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
Mar 8, 2019	Z-1184-2019	—	terminated	Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
Mar 8, 2019	Z-1178-2019	—	terminated	Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
Mar 8, 2019	Z-1181-2019	—	terminated	Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
Mar 8, 2019	Z-1187-2019	—	terminated	Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
Mar 8, 2019	Z-1179-2019	—	terminated	Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
Mar 8, 2019	Z-1186-2019	—	terminated	Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
Mar 8, 2019	Z-1185-2019	—	terminated	Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
Aug 3, 2017	Z-1337-2018	—	open, classified	"Chattering" when cutting burrs are used in bone.
Jan 8, 2010	Z-0797-2010	—	terminated	Units of the product in lot MH136952 may have been shipped without being sterilized.
Aug 18, 2009	Z-0635-2010	—	terminated	Gyrus ACMI received complaints of a problem with 3103PK, 3104PK, 3105PK, 915000PK, 915005PK, 915010PK - Gyrus ACMI PKS Seal Open Forceps. The metal shim between the jaws may detach during the procedure and fall into the surgical field. The detached shim may be undetected and be left behind in the patient. This circumstance could subsequently cause complications. Further use of this product should cease, affected product should be removed from stockrooms and returned to Gyrus ACMI.
Aug 18, 2009	Z-0632-2010	—	terminated	Gyrus ACMI received complaints of a problem with 3103PK, 3104PK, 3105PK, 915000PK, 915005PK, 915010PK - Gyrus ACMI PKS Seal Open Forceps. The metal shim between the jaws may detach during the procedure and fall into the surgical field. The detached shim may be undetected and be left behind in the patient. This circumstance could subsequently cause complications. Further use of this product should cease, affected product should be removed from stockrooms and returned to Gyrus ACMI.
Aug 18, 2009	Z-0636-2010	—	terminated	Gyrus ACMI received complaints of a problem with 3103PK, 3104PK, 3105PK, 915000PK, 915005PK, 915010PK - Gyrus ACMI PKS Seal Open Forceps. The metal shim between the jaws may detach during the procedure and fall into the surgical field. The detached shim may be undetected and be left behind in the patient. This circumstance could subsequently cause complications. Further use of this product should cease, affected product should be removed from stockrooms and returned to Gyrus ACMI.
Aug 18, 2009	Z-0633-2010	—	terminated	Gyrus ACMI received complaints of a problem with 3103PK, 3104PK, 3105PK, 915000PK, 915005PK, 915010PK - Gyrus ACMI PKS Seal Open Forceps. The metal shim between the jaws may detach during the procedure and fall into the surgical field. The detached shim may be undetected and be left behind in the patient. This circumstance could subsequently cause complications. Further use of this product should cease, affected product should be removed from stockrooms and returned to Gyrus ACMI.
Aug 18, 2009	Z-0637-2010	—	terminated	Gyrus ACMI received complaints of a problem with 3103PK, 3104PK, 3105PK, 915000PK, 915005PK, 915010PK - Gyrus ACMI PKS Seal Open Forceps. The metal shim between the jaws may detach during the procedure and fall into the surgical field. The detached shim may be undetected and be left behind in the patient. This circumstance could subsequently cause complications. Further use of this product should cease, affected product should be removed from stockrooms and returned to Gyrus ACMI.
Aug 18, 2009	Z-0634-2010	—	terminated	Gyrus ACMI received complaints of a problem with 3103PK, 3104PK, 3105PK, 915000PK, 915005PK, 915010PK - Gyrus ACMI PKS Seal Open Forceps. The metal shim between the jaws may detach during the procedure and fall into the surgical field. The detached shim may be undetected and be left behind in the patient. This circumstance could subsequently cause complications. Further use of this product should cease, affected product should be removed from stockrooms and returned to Gyrus ACMI.
Oct 1, 2008	Z-0273-2009	—	terminated	Sterility may be compromised
Jun 25, 2008	Z-2226-2008	—	terminated	Particulate matter in the catheter
May 23, 2007	Z-1073-2007	—	terminated	Sterilization Instructions not adequate for sterilizing.
Feb 19, 2007	Z-0613-2007	—	terminated	Product sterility may be compromised due to failure of the tray seal packaging
Feb 19, 2007	Z-0615-2007	—	terminated	Product sterility may be compromised due to failure of the tray seal packaging
Feb 19, 2007	Z-0614-2007	—	terminated	Product sterility may be compromised due to failure of the tray seal packaging