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510(k) K890463

ULTRASOUND PROCEDURE TRAY AMNICENTESIS TRAY by Critical Specialties, Inc. — Product Code HIO

K890463 is an FDA 510(k) premarket notification submitted by Critical Specialties, Inc. for the device "ULTRASOUND PROCEDURE TRAY AMNICENTESIS TRAY". The FDA issued a decision of Substantially Equivalent (with conditions) on April 7, 1989. The device falls under product code HIO (Sampler, Amniotic Fluid (Amniocentesis Tray)), a Class I device regulated under 21 CFR 884.1550.

Clearance Details

Decision
SESD (Substantially Equivalent (with conditions))
Decision Date
April 7, 1989
Date Received
January 30, 1989
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 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)
  • K915863 — MEGA AMNIOCENTESIS KIT (March 30, 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)

FDA data resources