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510(k) K926344

HYDROPHILIC COATED GUIDEWIRE by Surgitek — Product Code KNY

K926344 is an FDA 510(k) premarket notification submitted by Surgitek for the device "HYDROPHILIC COATED GUIDEWIRE". The FDA issued a decision of Substantially Equivalent on March 5, 1993. The device falls under product code KNY (Accessories, Catheter, G-U), a Class II device regulated under 21 CFR 876.5130. Surgitek has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 1993
Date Received
December 17, 1992
Clearance Type
Traditional
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 Surgitek

  • K946296 — QUADRA-COIL URETERAL STENT (March 6, 1995)
  • K944391 — OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEM (February 7, 1995)
  • K943491 — RIGHT ANGLE UROLOGIC LASER FIBER (August 5, 1994)
  • K941952 — SURGITEK INFUSER (May 24, 1994)
  • K933261 — GRASPING FORCEPS (January 11, 1994)
  • K933260 — HELICAL STONE/FLATWIRE STONE BASKETS (January 11, 1994)
  • K930733 — URETERAL STENT (July 23, 1993)
  • K930483 — URETERAL CATHETER (July 16, 1993)
  • K920451 — ENDOTEK ULTRA SYSTEM (September 17, 1992)
  • K922542 — GRASPING FORCEPS (August 19, 1992)

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)
  • K131803 — GUARDIAN URETHRAL SHEATH (August 20, 2013)
  • 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)

FDA data resources