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510(k) K896806

CATHETER PLUG/PROTECTOR by Westmark, Sterile Packing Systems, Inc. (Sps) — Product Code KNY

K896806 is an FDA 510(k) premarket notification submitted by Westmark, Sterile Packing Systems, Inc. (Sps) for the device "CATHETER PLUG/PROTECTOR". The FDA issued a decision of Substantially Equivalent on February 26, 1990. The device falls under product code KNY (Accessories, Catheter, G-U), a Class II device regulated under 21 CFR 876.5130. Westmark, Sterile Packing Systems, Inc. (Sps) has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1990
Date Received
December 1, 1989
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 Westmark, Sterile Packing Systems, Inc. (Sps)

  • K896800 — IRRIGATION TRAY (May 24, 1990)
  • K896799 — PARACERVICAL/PUDENDAL TRAYS (April 23, 1990)
  • K896559 — INFANT FEEDING TUBE (March 13, 1990)
  • K896794 — SPECIMEN CONTAINER (March 1, 1990)
  • K896798 — TRACHEOSTOMY TRAY (February 22, 1990)
  • K896797 — SUCTION CATHETER KIT (February 16, 1990)
  • K896215 — MERCY HIP/KNEE PACK (February 13, 1990)
  • K896804 — MANIFOLD (February 8, 1990)
  • K896557 — YANKAUER SUCTION TUBE-FLEXIBLE TYPE (February 6, 1990)
  • K896562 — STOPCOCK (February 6, 1990)

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