Home / 510(k) Clearances / K131803

510(k) K131803

GUARDIAN URETHRAL SHEATH by Solace Therapeutics — Product Code KNY

K131803 is an FDA 510(k) premarket notification submitted by Solace Therapeutics for the device "GUARDIAN URETHRAL SHEATH". The FDA issued a decision of Substantially Equivalent on August 20, 2013. The device falls under product code KNY (Accessories, Catheter, G-U), a Class II device regulated under 21 CFR 876.5130. Solace Therapeutics has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 2013
Date Received
June 19, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Catheter, G-U
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Solace Therapeutics

  • K170862 — Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree L (December 19, 2017)
  • K162356 — Vesair Cystoscopic Sheath (March 2, 2017)
  • K141252 — GUARDIAN URETHRAL SHEATH (June 9, 2014)

Other clearances for product code KNY

  • K182144 — Bi-Flex Evo (September 7, 2018)
  • K162356 — Vesair Cystoscopic Sheath (March 2, 2017)
  • K140441 — BI-FLEX URETERAL ACCESS SHEATH (June 17, 2014)
  • K140562 — WIJAY EZ-VOID EXTERNAL CATHETER VALVE (June 16, 2014)
  • K141252 — GUARDIAN URETHRAL SHEATH (June 9, 2014)
  • K123170 — VARI-PASS VARIABLE LENGTH ACCESS SHEATH (February 4, 2013)
  • K120160 — ROCAMED ROCAUS PLATINUM (May 14, 2012)
  • K112209 — PREFILLED CATHETER INFLATION SYRINGE (September 8, 2011)
  • K090121 — PRE-FILLED CATHETER INFLATION SYRINGE (April 15, 2009)
  • K052298 — CYSTOGLIDE INTRODUCER SHEATH (December 12, 2006)

FDA data resources