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510(k) K862365

NEEDLE FOR AMNIOCENTESIS AND CYST PUNCTURE by Swemed Laboratories, Inc. — Product Code HIO

K862365 is an FDA 510(k) premarket notification submitted by Swemed Laboratories, Inc. for the device "NEEDLE FOR AMNIOCENTESIS AND CYST PUNCTURE". The FDA issued a decision of Substantially Equivalent on July 7, 1986. The device falls under product code HIO (Sampler, Amniotic Fluid (Amniocentesis Tray)), a Class I device regulated under 21 CFR 884.1550. Swemed Laboratories, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 7, 1986
Date Received
June 24, 1986
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 Swemed Laboratories, Inc.

  • K862364 — NEEDLE GUIDE (FOR ULTRASOUND TRANSDUCERS) (August 19, 1986)

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