Guardian Urethral Sheath

FDA 510(k) K131803 · Solace Therapeutics

Substantially Equivalent

510(k) numberK131803

Submission

Device name
Guardian Urethral Sheath
Applicant
Solace Therapeutics
Farmingham, MA, US
Received
June 19, 2013
Decision date
August 20, 2013
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KNY – Accessories, Catheter, G-U
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5130
Specialty
Gastroenterology, Urology

Other 510(k)s with product code KNY

510(k)DeviceApplicantDecision
K260919Transurethral Catheter Safety Valve (TUCSV) (80050)KNY · Traditional Class Medical , Ltd.08/05/2026SE
K182144Bi-Flex EvoKNY · Special Promepla Sam09/07/2018SE
K162356Vesair Cystoscopic SheathKNY · Special Solace Therapeutics03/02/2017SE
K140441Bi-Flex Ureteral Access SheathKNY · Traditional Promepla Sam06/17/2014SE
K140562Wijay Ez-Void External Catheter ValveKNY · Traditional Leomed, LLC06/16/2014SE
K141252Guardian Urethral SheathKNY · Special Solace Therapeutics06/09/2014SE
K123170Vari-Pass Variable Length Access SheathKNY · Special Olympus Surgical Technologies America02/04/2013SE
K120160Rocamed Rocaus PlatinumKNY · Traditional Promepla Sam05/14/2012SE
K112209Prefilled Catheter Inflation SyringeKNY · Special Avail Medical Products, Inc.09/08/2011SE
K090121Pre-Filled Catheter Inflation SyringeKNY · Special Avail Medical Products, Inc.04/15/2009SE

More from Avail Medical Products, Inc.

510(k)DeviceDecision
K170862Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long…FAJ · Traditional 12/19/2017SE
K162356Vesair Cystoscopic SheathKNY · Special 03/02/2017SE
K141252Guardian Urethral SheathKNY · Special 06/09/2014SE

Questions and answers

When was Guardian Urethral Sheath cleared by the FDA?

Guardian Urethral Sheath (K131803) received a 510(k) decision of Substantially Equivalent on August 20, 2013, 62 days after the submission was received.

What is the product code of K131803?

The FDA product code is KNY – Accessories, Catheter, G-U, a Class II (moderate risk) device regulated under 21 CFR 876.5130.