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510(k) K955072

LAMINARIA by Cti Corp., Ltd. — Product Code HDY

K955072 is an FDA 510(k) premarket notification submitted by Cti Corp., Ltd. for the device "LAMINARIA". The FDA issued a decision of Substantially Equivalent on May 22, 1996. The device falls under product code HDY (Dilator, Cervical, Hygroscopic-Laminaria), a Class II device regulated under 21 CFR 884.4260.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 1996
Date Received
November 6, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Cervical, Hygroscopic-Laminaria
Device Class
Class II
Regulation Number
884.4260
Review Panel
OB
Submission Type

Other clearances for product code HDY

  • K040625 — ATAD ARD CATHETER (January 18, 2005)
  • K021012 — LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM (June 25, 2002)
  • K011512 — MMODIFICATION TO LAMINARIA (July 9, 2001)
  • K892220 — LAMINARIA TENT (June 14, 1989)
  • K881295 — LAMINARIA CUREX (August 10, 1988)
  • K881312 — LAMINARIA (May 23, 1988)
  • K880196 — LAMINARIA (May 6, 1988)
  • K845006 — SUN MEDICAL LAMINARIA CERVICAL DILATOR (May 1, 1985)
  • K833068 — LAMINARIA JAPONICA CERVICAL DILATOR (February 4, 1984)
  • K782067 — DILATOR, MIZUTANI LAMINARIA TENT (January 3, 1979)

FDA data resources