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510(k) K915863

MEGA AMNIOCENTESIS KIT by Mega Medical, Inc. — Product Code HIO

K915863 is an FDA 510(k) premarket notification submitted by Mega Medical, Inc. for the device "MEGA AMNIOCENTESIS KIT". The FDA issued a decision of Substantially Equivalent (kit, denovo) on March 30, 1992. The device falls under product code HIO (Sampler, Amniotic Fluid (Amniocentesis Tray)), a Class I device regulated under 21 CFR 884.1550. Mega Medical, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
March 30, 1992
Date Received
December 31, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sampler, Amniotic Fluid (Amniocentesis Tray)
Device Class
Class I
Regulation Number
884.1550
Review Panel
OB
Submission Type

Other clearances by Mega Medical, Inc.

  • K913397 — MEGA ANGIOGRAM KIT (October 31, 1991)
  • K913317 — MEGA ARTHROGRAM KIT (October 31, 1991)
  • K912445 — MEGA CONTINUOUS EPIDURAL ANESTHESIA KIT (October 18, 1991)
  • K913382 — MEGA PARACENTESIS KIT (October 8, 1991)
  • K912322 — MEGA SPINAL ANESTHESIA KIT (September 26, 1991)
  • K912564 — MEGA PERICARDIOCENTESIS KIT (September 5, 1991)

Other clearances for product code HIO

  • K960203 — G.E. STERILE AMNIOCENTESIS TRAY (March 14, 1996)
  • K955679 — RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAY (March 12, 1996)
  • K914419 — AMNIOTEST(TM) (September 1, 1993)
  • K922960 — VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLE (November 5, 1992)
  • K921738 — SONO-VU US(TM), MODIFICATION (April 27, 1992)
  • K904583 — SONO-VU US(TM) (June 24, 1991)
  • K901643 — ISOFLO(TM) AMNIOCENTESIS TRAY (July 25, 1990)
  • K900021 — PERCU-SET(TM) (March 29, 1990)
  • K896031 — AMNIOTIC FLUID SAMPLER (AMNIOCENTESIS TRAY) (January 12, 1990)
  • K894031 — PHARMASEAL GENETIC AMNIOCENTESIS TRAY (August 4, 1989)

FDA data resources