Gyrus Medical, Ltd.
Country not established FDA
- Devices
- 23
- Registrations
- FDA
- FDA recalls
- 6
At a glance
Market reach
- United States
- FDA establishment, FDA recalls
What Gyrus Medical, Ltd. makes
The company manufactures electro-surgical systems and accessories for urological and gynecological procedures, including resectoscopes, plasma-based endourology tools, and conductivity probes for urinary assessments. These devices are designed for tissue resection, ablation, and diagnostic applications in endoscopic surgeries, such as transurethral resection and hysteroscopic procedures.
The portfolio includes Class I and Class II devices, with regulatory submissions recorded under the FDA’s 510(k) pathway. Products are listed in the U.S. regulatory database, adhering to applicable medical device classifications and clearance requirements.
Catalogue
Search and filter all 23 devicesFDA recalls
2014
- 27 Aug 2014 Z-0100-2015 Class II Terminated Due to an anomaly in the packaging process, it is possible that a defective seal could be present that may allow a breach of the package's sterile barrier and may compromise the sterility of the product.
Full distribution text
- 8 Jul 2014 Z-2269-2014 Class II Terminated Falope-Ring Dilator for Reusable Falope-Ring Band Applicators have been sold as a stand-alone non-sterile component. The dilator is intended to assist placement of the Falope-Ring band on the reusable Falope applicator.
Full distribution text
- 19 Feb 2014 Z-1196-2014 Class II Terminated Due to an anomaly in the packaging process for specific lots of Disposable Falope-Ring Band Kit, it is possible that a defective seal could be present that may allow a breach of the package's sterile barrier and may compromise the sterility of the product. The breach may or may not be easily seen.
- 27 Aug 2014 Z-0100-2015 Class II Terminated Due to an anomaly in the packaging process, it is possible that a defective seal could be present that may allow a breach of the package's sterile barrier and may compromise the sterility of the product.
2013
- 24 Jul 2013 Z-1983-2013 Class II Terminated On April 29, 2013 Olympus Surgical Technologies America R&D received results from an accelerated aging study conducted as part of a new market submission. The study found that one of 60 Dissector units that underwent 3 year accelerated aging failed the dye penetration test indicating that the seal on sterile packaging was compromised. The dissector products are labeled with a 3 year shelf life.
Full distribution text
- 24 Jul 2013 Z-1983-2013 Class II Terminated On April 29, 2013 Olympus Surgical Technologies America R&D received results from an accelerated aging study conducted as part of a new market submission. The study found that one of 60 Dissector units that underwent 3 year accelerated aging failed the dye penetration test indicating that the seal on sterile packaging was compromised. The dissector products are labeled with a 3 year shelf life.
2006
- 15 May 2006 Z-1175-06 Unclassified (pre-2012) Terminated Gyrus ACMI has identified a product issue wherein their PlasmaSEAL Open Forceps, models 2103PK and 917015PK, may not deliver adequate hemostasis during use. Although Gyrus ACMI has had no reports of serious injury to patient, testing indicated that the possibility exists.
Full distribution text
- 15 May 2006 Z-1175-06 Unclassified (pre-2012) Terminated Gyrus ACMI has identified a product issue wherein their PlasmaSEAL Open Forceps, models 2103PK and 917015PK, may not deliver adequate hemostasis during use. Although Gyrus ACMI has had no reports of serious injury to patient, testing indicated that the possibility exists.
2003
- 5 Dec 2003 Z-0841-04 Unclassified (pre-2012) Terminated The generator may malfunction when used in close proximity to a monopolar generator.
FDA establishments
- Gyrus Medical Ltd. CARDIFF Wales · GB FEI 3002807134
Frequently asked questions
How many devices does Gyrus Medical, Ltd. have in the registry?
The registry currently lists 23 devices for Gyrus Medical, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gyrus Medical, Ltd.'s devices?
Among its 23 most recently registered devices, Gyrus Medical, Ltd. has devices listed in FDA 510(k) (23 devices).
What risk classes do Gyrus Medical, Ltd.'s devices fall under?
Among its 23 most recently registered devices, the classes recorded for Gyrus Medical, Ltd.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Gyrus Medical, Ltd.?
FDA recall records list 6 recalls initiated by Gyrus Medical, Ltd., the most recent initiated on 27 Aug 2014. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Gyrus Medical, Ltd. in the registry?
The most recently registered devices listed for Gyrus Medical, Ltd. include GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODE, GYRUS OPEN FORCEPS, EVEREST LP BIPOLAR SCISSORS AND GYRUS LP BIPOLAR SCISSORS and ZIP OPEN FORCEPS WITH ELECTROSURGICAL CUT.
Which FDA establishments are linked to Gyrus Medical, Ltd.?
1 FDA establishment is linked to Gyrus Medical, Ltd. in the registry; they are listed on the company page.