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510(k) K905812

INTRAUTERINE CATHETER SET by Epcom Medical Systems, Inc. — Product Code HGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 1991
Date Received
December 28, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intrauterine And Introducer
Device Class
Class II
Regulation Number
884.2700
Review Panel
OB
Submission Type

Other clearances by Epcom Medical Systems, Inc.

  • K910518 — GLOVE-N-GEL AMNIOTOMY KIT (May 9, 1991)
  • K881414 — CERVICATH (June 14, 1988)
  • K871079 — FETALFLEX FETAL ELECTRODE (July 13, 1987)
  • K844338 — 1URO-LOG HOME DIAGNOSTIC PACK (February 25, 1985)
  • K844503 — UROSTRESSTIK DIAGNOSTIC CYSTOMETRY PACK (January 2, 1985)
  • K841805 — OBSTETRICAL DOPPLER (June 19, 1984)
  • K831113 — EPCOM EMS-310 INTRAPARTUM MONITOR (August 12, 1983)
  • K831114 — EPCOM EMS-330 FREEDOM I TELEDOP OBSTET (August 12, 1983)
  • K831115 — EPCOM EMS-320 REMOTE MONITORSCOPE (August 12, 1983)
  • K831112 — EPCOM VCU-1 VACUUM SYSTEM & CURETTE (June 30, 1983)

Other clearances for product code HGS

  • K914387 — TRANSCERVICAL INTRAUTERINE KIT (December 30, 1991)