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510(k) K951995

KARL STORZ CATHETERS, MANDRIN, PLUGS, CONNECTOR by Karl Storz Endoskop GmbH — Product Code KNY

K951995 is an FDA 510(k) premarket notification submitted by Karl Storz Endoskop GmbH for the device "KARL STORZ CATHETERS, MANDRIN, PLUGS, CONNECTOR". The FDA issued a decision of Substantially Equivalent on May 24, 1995. The device falls under product code KNY (Accessories, Catheter, G-U), a Class II device regulated under 21 CFR 876.5130. Karl Storz Endoskop GmbH has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 1995
Date Received
April 28, 1995
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 Karl Storz Endoskop GmbH

  • K973068 — KSEA INSTRUMENT SET FOR SAPHENOUS VEIN HARVESTING (November 7, 1997)
  • K961702 — KSEA VAPORIZATION ELECTRODES (August 29, 1996)
  • K953368 — LUER, JACKSON TRACHEA TUBES, LUER SPEAKING TRACHEA TUBES (September 18, 1995)
  • K943713 — TORCARS,CANNULAE,SHEATHS,OBTURATORS (June 30, 1995)
  • K943053 — KSEA SEMM TISSUR PUNCH (March 21, 1995)
  • K943435 — CHOLANGIOGRAPHY SET (November 7, 1994)
  • K944823 — KARL STORZ INSULATED DISSECTING CANNULAE, CANNULAE, SUCTION TUBES, INSERT TUBES (November 2, 1994)
  • K943904 — RIGID TELESCOPES (October 14, 1994)
  • K943697 — TROCARS,CANNULAE,SHEATHS,OBTURATORS (September 14, 1994)
  • K943816 — TROCARS,CANNULAE, SHEATHS (August 24, 1994)

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