Data / Medical devices / United States / Gyrus Acmi, Inc.
Gyrus Acmi, Inc.: FDA-registered device maker in Westborough, MA, United States, 4 510(k) clearances and 1 PMA approval
Gyrus Acmi, Inc. is registered with the FDA (registration 3003790304) in Westborough, MA, United States. It lists 12 device types. The FDA files 4 510(k) clearances and 1 PMA approval under its listings, the newest dated January 19, 2022. 14 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3003790304
- Address
- 800 West Park Drive, Westborough, MA, United States, 01581
- Owner or operator
- OLYMPUS CORPORATION (9067818)
- Roles
- Specification developer
- First device listed
- March 3, 2008
- Registered through
- 2027
- Brand names listed
- Aspiration needle, Celeris, EZDilate, Holster, IBV Valve, IBV Valve System, SecurCatch, ShockPulse and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Biopsy Needle | FCG | 2 | Specification developer | accessdata.fda.gov |
| Bronchoscope Accessory | KTI | 2 | Specification developer | accessdata.fda.gov |
| Device, Digital Image Storage, Radiological | LMB | 1 | Specification developer | accessdata.fda.gov |
| Dilator, Esophageal | KNQ | 2 | Specification developer | accessdata.fda.gov |
| Dislodger, Stone, Flexible | FGO | 2 | Specification developer | accessdata.fda.gov |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | 2 | Specification developer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Specification developer | accessdata.fda.gov |
| Lithotriptor, Ultrasonic | FEO | 2 | Specification developer | accessdata.fda.gov |
| One-Way Air-Leak Valve | OAZ | f | Specification developer | accessdata.fda.gov |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | 2 | Specification developer | accessdata.fda.gov |
| System, Digital Image Communications, Radiological | LMD | 1 | Specification developer | accessdata.fda.gov |
| Valve, Pulmonary | NJK | 3 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 19, 2022 | K212650 | Celeris, Disposable Sinus Debrider | ERL | Substantially Equivalent | Gyrus Acmi, Inc. | accessdata.fda.gov |
| March 18, 2020 | K193517 | ViziShot 2 FLEX | KTI | Substantially Equivalent | Olympus Surgical Technologies America | accessdata.fda.gov |
| March 8, 2018 | K180086 | Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheter | FGE | Substantially Equivalent | Gyrus Acmi, Inc. | accessdata.fda.gov |
| November 13, 2014 | K142428 | Shock Pulse-SE Lithotripsy System CYBERWAND II | FEO | Substantially Equivalent | Cybersonics, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| December 3, 2018 | P180007 | Spiration® Valve System | NJK | 11 | August 20, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 17, 2018 | 79762 | Class II | Terminated | Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators, Catalog No C650-129A (00821925008700) The cord consists of a single conductor stranded wire terminated with plugs that connect to a generator on one end and | There is a potential for the cord to spark and cause a fire. | accessdata.fda.gov |
| May 8, 2015 | 71238 | Class II | Terminated | Gyrus ACMI Diego Elite Tubeset; intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT, Sinus/Rhinology, Nasopharyngeal/Laryngology, and Head & Neck procedure | Potential lack of sterility assurance. | accessdata.fda.gov |
| October 21, 2014 | 69584 | Class II | Terminated | Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan). Sterile EO. Single Use Only. The disposable Falope-Ring Band Applicator is a sterile, two-band, dua | All packages of Falope Ring Band Applicator kits are being recalled due to compromises in sterile packaging that could be associated with bacterial contamination that might lead to patient infection. | accessdata.fda.gov |
| May 24, 2013 | 65255 | Class II | Terminated | GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 130715, Rx only, STERILE EO, GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01722-2104 Disposable myringotomy knife intended to perforate the | lack of sterility assurance | accessdata.fda.gov |
| October 17, 2012 | 63629 | Class II | Terminated | PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC., Tympanostomy tube | One lot of tympanostomy tubes were manufactured with silicon that was found to be contaminated with ethylene vinyl acetate copolymer. | accessdata.fda.gov |
| April 15, 2011 | 58650 | Not yet classified | Terminated | Gyrus ACMI, REF 25 BX, PTFE Coated 3 cm Flexible Tip Guidewire,.035" x 150 cm, Sterile EO, Rx Only, Gyrus ACMI, Inc. 136 Turnpike Road,Southborough, MA 01772-2104 USA Ureteral guidewires are used to establish access in t | Gyrus ACMI, Inc. wants to bring a recall issue to their customers attention concerning one lot of their 25BX-PTFE Coated 3 cm Flexible Tip Guidewire. As a result of a manufacturing error in the production this lot of guidewires, some units of product were loaded in the dispenser backwards. In such cases, the stiff end of the guidewire would be dispensed from | accessdata.fda.gov |
| August 6, 2010 | 56304 | Not yet classified | Terminated | GYRUS ACMI, dissector PlasmaKnife", REF 7035-3005, Rx only, STERILE R, CE 0344, 161416-CA, MANUFACTURED FOR; GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01722-2104, USA, EC REP, GYRUS MEDICAL LIMITED, FORTRAN R | Lack of sterility assurance due to compromised package seals. | accessdata.fda.gov |
| August 3, 2010 | 56626 | Not yet classified | Terminated | The Gyrus ACMI Pleatman Sac Tissue Removal System facilitates removal of specimens while minimizing contamination of the abdominal cavity or wound tract. The system contains one (1) Sac and one (1) obturator in a sterile | Gyrus Medical, Inc. has issued a Urgent Medical Device Recall for the Gyrus ACMI product 004942-903 - Pleatman Sac Tissue Removal System, sold as lot 186540FC with an expiration date of 06/2015. As a result of a manufacturing error in the production of the trays used in this lot, it is possible that a crack could form that would compromise the package integr | accessdata.fda.gov |
| January 8, 2010 | 54356 | Not yet classified | Terminated | MICRON BOBBIN VENT TUBE, 1.27 MM I.D., TITANIUM, REF 145281-ENT, QTY 1, STERILE EO, GYRUS ACMI INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01772 USA. Intended to be implanted for ventilation or drainage of the middle ear. | Units of the product in lot MH136952 may have been shipped without being sterilized. | accessdata.fda.gov |
| August 18, 2009 | 53890 | Not yet classified | Terminated | Gyrus ACMI PKS Seal Open Forceps, model 3103PK, 9-3/4" curved. Sterile EO. The device is intended to be used with the PlasmaKinetic electrosurgical generator, software version 1.61 or greater required or the PlasmaKineti | 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 complicati | accessdata.fda.gov |
| October 1, 2008 | 49554 | Not yet classified | Terminated | Gyrus ACMI, Inc. dissector PlasmaKnife (DPK) Catalog No: 7035-3005 A single use only bipolar electrosurgical instrument with the ability to cut and coagulate soft tissue in head and neck surgery within an ambient air env | Sterility may be compromised | accessdata.fda.gov |
| June 25, 2008 | 48691 | Not yet classified | Terminated | Gyrus ACMI 10 Fr. Dual Lumen Catheter Reference Number: 608 BX (Box of 5) and 608 (single unit) This product has multiple uses, including ureteral dilation, anesthetic injection, stone displacement, contrast injection, a | Particulate matter in the catheter | accessdata.fda.gov |
| May 23, 2007 | 37999 | Not yet classified | Terminated | Gyrus CyberWand Ultrasonic Lithotripter System includes: CW-USLS CyberWand USL System CW-USLT CyberWand USL Transducer CW-USLRBP CyberWand USL Renal/Bladder Probe Set CW-USLTT CyberWand USL Transducer Sterilization Tray | Sterilization Instructions not adequate for sterilizing. | accessdata.fda.gov |
| February 19, 2007 | 37404 | Not yet classified | Terminated | Gyrus ACMI Tripolar Ultra Cutting Forceps: 5 mm X 32 cm-Reference Number: TRU5-32 | Product sterility may be compromised due to failure of the tray seal packaging | accessdata.fda.gov |
Compare with other makers
- All makers of System, Digital Image Communications, Radiological
- All makers of Bronchoscope Accessory
- All makers of Biopsy Needle
- All makers of Instrument, Manual, Surgical, General Use
- All makers of Valve, Pulmonary
Updated August 20, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.