Percutaneous Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
What Percutaneous Systems, Inc. makes
Percutaneous Systems, Inc. manufactures urological devices for stone management and ureteral access, including accordion-style stone retrieval tools (models AC281205, AC3814510, COAC12005–COA20015), dilating introducer sheaths (Cystoglide), ureteral access sheaths (Microverter), and ureteral catheters (Slip Urology). These products are designed for minimally invasive procedures in the treatment of kidney and ureteral stones.
The company’s devices are classified as Class II under FDA regulations and are authorised via the 510(k) clearance pathway. Products are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Cystoglide Dilating Introducer Sheath Ref K052134
Regimes: 510(k) Registry: 510(k)Slip Urology Introducer Sheath Ref K040520
Regimes: 510(k) Registry: 510(k)Microverter Ureteral Access Sheath Ref K042877
Regimes: 510(k) Registry: 510(k)Slip Urology Catheter Ref K040519
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Percutaneous Systems, Inc. have in the registry?
The registry currently lists 6 devices for Percutaneous Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Percutaneous Systems, Inc.'s devices?
Among its 6 most recently registered devices, Percutaneous Systems, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Percutaneous Systems, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Percutaneous Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Percutaneous Systems, Inc. in the registry?
The most recently registered devices listed for Percutaneous Systems, Inc. include ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510, COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015, CYSTOGLIDE DILATING INTRODUCER SHEATH and SLIP UROLOGY INTRODUCER SHEATH.