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510(k) K021012

LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM by Quality Medical Solusions, LLC — Product Code HDY

K021012 is an FDA 510(k) premarket notification submitted by Quality Medical Solusions, LLC for the device "LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM". The FDA issued a decision of Substantially Equivalent on June 25, 2002. 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
June 25, 2002
Date Received
March 29, 2002
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)
  • K011512 — MMODIFICATION TO LAMINARIA (July 9, 2001)
  • K955072 — LAMINARIA (May 22, 1996)
  • 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