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510(k) K871042

URINE METER, 250CC by Salt Creek Medical Technologies — Product Code KNX

K871042 is an FDA 510(k) premarket notification submitted by Salt Creek Medical Technologies for the device "URINE METER, 250CC". The FDA issued a decision of Substantially Equivalent on March 25, 1987. The device falls under product code KNX (Collector, Urine, (And Accessories) For Indwelling Catheter), a Class II device regulated under 21 CFR 876.5250. Salt Creek Medical Technologies has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 1987
Date Received
March 17, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Collector, Urine, (And Accessories) For Indwelling Catheter
Device Class
Class II
Regulation Number
876.5250
Review Panel
GU
Submission Type

Other clearances by Salt Creek Medical Technologies

  • K864683 — NEONATAL FEEDING KIT (April 17, 1987)
  • K871075 — SCMT UMBILICAL CLAMP (March 23, 1987)
  • K871087 — S.C.M.T. PERFORATOR (March 23, 1987)
  • K864296 — S.C.T. MULTI PORT, INJECTION SITE (March 2, 1987)
  • K864682 — SALT CREEK P.I. TRAY (January 6, 1987)
  • K864692 — EXTENSION SETS (December 18, 1986)
  • K864693 — I.V. START KITS (December 16, 1986)

Other clearances for product code KNX

  • K110518 — IBAG (June 24, 2011)
  • K973364 — 4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG (March 17, 1998)
  • K972887 — MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG (December 11, 1997)
  • K971271 — BESECURE EXTERNAL URINARY COLLECTION SYSTEM (August 18, 1997)
  • K971929 — AMSINO URINARY LEG BAG (August 6, 1997)
  • K971764 — WELCON HUE-VU URINARY DRAINAGE BAG (July 29, 1997)
  • K964690 — LIBERTY VALVE (March 21, 1997)
  • K964745 — AMSINO URINARY DRAINAGE BAG (March 18, 1997)
  • K962652 — URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749) (October 4, 1996)
  • K960949 — PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167 (April 19, 1996)

FDA data resources