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510(k) K831112

EPCOM VCU-1 VACUUM SYSTEM & CURETTE by Epcom Medical Systems, Inc. — Product Code HHI

K831112 is an FDA 510(k) premarket notification submitted by Epcom Medical Systems, Inc. for the device "EPCOM VCU-1 VACUUM SYSTEM & CURETTE". The FDA issued a decision of Substantially Equivalent on June 30, 1983. The device falls under product code HHI (System, Abortion, Vacuum), a Class II device regulated under 21 CFR 884.5070. Epcom Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 1983
Date Received
April 5, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Abortion, Vacuum
Device Class
Class II
Regulation Number
884.5070
Review Panel
OB
Submission Type

Other clearances by Epcom Medical Systems, Inc.

  • K910518 — GLOVE-N-GEL AMNIOTOMY KIT (May 9, 1991)
  • K905812 — INTRAUTERINE CATHETER SET (January 31, 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)
  • K831114 — EPCOM EMS-330 FREEDOM I TELEDOP OBSTET (August 12, 1983)
  • K831115 — EPCOM EMS-320 REMOTE MONITORSCOPE (August 12, 1983)
  • K831113 — EPCOM EMS-310 INTRAPARTUM MONITOR (August 12, 1983)

Other clearances for product code HHI

  • K171440 — Berkeley VC-10 Vacuum Curettage System (September 29, 2017)
  • K030935 — BERKELEY V-10 VACUUM CURETTAGE SYSTEM (June 23, 2003)
  • K983181 — CYTOPREP (November 16, 1998)
  • K931205 — MEDI VAC SPECIMEN COLLECTOR AND TRANSPORTER (March 15, 1994)
  • K904160 — CYTOSMEAR BRUSH (November 2, 1990)
  • K900641 — CANNULA, SUCTION UTERINE (March 30, 1990)
  • K900642 — SWIVEL ADAPTER (March 19, 1990)
  • K880734 — SCENTED OR SCENTED DEODORIZED MENSTRUAL PADS (April 25, 1988)
  • K873552 — CANNULA AND GENERAL PURPOSE ASPIRATOR (November 25, 1987)
  • K870574 — COSMEDTECH GENERAL ASPIRATOR (March 5, 1987)

FDA data resources