Guardian Urethral Sheath

FDA 510(k) K141252 · Solace Therapeutics

Substantially Equivalent

510(k) numberK141252

Submission

Device name
Guardian Urethral Sheath
Applicant
Solace Therapeutics
Farmingham, MA, US
Received
May 14, 2014
Decision date
June 9, 2014
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) statement 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

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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
K131803Guardian Urethral SheathKNY · Special Solace Therapeutics08/20/2013SE
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
K131803Guardian Urethral SheathKNY · Special 08/20/2013SE

Questions and answers

When was Guardian Urethral Sheath cleared by the FDA?

Guardian Urethral Sheath (K141252) received a 510(k) decision of Substantially Equivalent on June 9, 2014, 26 days after the submission was received.

What is the product code of K141252?

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