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510(k) K813494

WATERS ILEAL RESERVOIR CATHETER by Waters Instruments, Inc. — Product Code KPH

K813494 is an FDA 510(k) premarket notification submitted by Waters Instruments, Inc. for the device "WATERS ILEAL RESERVOIR CATHETER". The FDA issued a decision of Substantially Equivalent on December 31, 1981. The device falls under product code KPH (Catheter, Rectal For Continent Ileostomy), a Class I device regulated under 21 CFR 876.5030. Waters Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 1981
Date Received
December 14, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Rectal For Continent Ileostomy
Device Class
Class I
Regulation Number
876.5030
Review Panel
GU
Submission Type

Other clearances by Waters Instruments, Inc.

  • K053169 — RM3 RENAL PRESERVATION SYSTEM (January 17, 2006)
  • K042224 — RM3 RENAL PRESERVATION SYSTEM (October 22, 2004)
  • K971571 — RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT (July 29, 1997)
  • K921519 — OXICOM-2100 (October 23, 1992)
  • K911207 — OXICOMPLUS (August 26, 1991)
  • K863210 — VELCOM-100 (November 26, 1986)
  • K862161 — OSC-80 OXIMETER (August 18, 1986)
  • K852909 — MVP - 6000 (November 14, 1985)
  • K834408 — TX-2 THERMAL DILUTION CARDIAC OUTPUT (August 23, 1984)
  • K841876 — POLYURETHANE THERMAL DILUTION CATHET (July 13, 1984)

FDA data resources