Suros Surgical Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Suros Surgical Systems, Inc. makes
Suros Surgical Systems, Inc. manufactures vacuum-assisted core biopsy devices for tissue sampling and a tissue site marking system for procedural guidance. These tools are designed for minimally invasive diagnostic procedures in soft tissue and breast imaging.
The company’s portfolio is regulated under FDA Class II devices, with products authorised via the 510(k) pathway. The devices are listed in the FDA’s 510(k) registry, and the company is headquartered in the United States.
Catalogue
Vacuum Assisted Core Biopsy Device Ref K034021
Regimes: 510(k) Registry: 510(k)Vacuum Assisted Core Biopsy Device Ref K042290
Regimes: 510(k) Registry: 510(k)Tissue Site Marking System Ref K062528
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 2 recalls initiated by Suros Surgical Systems, Inc., the earliest on 2006-05-25 and the most recent on 2006-12-15. By recorded status: 2 terminated. The reasons filed fall into these groups: sterility or contamination and packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2006
- 15 Dec 2006 Z-0362-2007 Unclassified (pre-2012) Terminated The handpiece package may have an incorrect part number on the inner package. Error could result in over-penetration of the biopsy needle.
- 25 May 2006 Z-1160-06 Unclassified (pre-2012) Terminated Lack of assurance of sterility, as package may have a seal defect (improperly sealed primary packaging).
Frequently asked questions
How many devices does Suros Surgical Systems, Inc. have in the registry?
The registry currently lists 3 devices for Suros Surgical Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Suros Surgical Systems, Inc.'s devices?
Among its 3 most recently registered devices, Suros Surgical Systems, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Suros Surgical Systems, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Suros Surgical Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Suros Surgical Systems, Inc.?
FDA recall records list 2 recalls initiated by Suros Surgical Systems, Inc., the most recent initiated on 15 Dec 2006. 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 Suros Surgical Systems, Inc. in the registry?
The most recently registered devices listed for Suros Surgical Systems, Inc. include VACUUM ASSISTED CORE BIOPSY DEVICE and TISSUE SITE MARKING SYSTEM.