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510(k) K880196

LAMINARIA by Medgyn Products, Inc. — Product Code HDY

K880196 is an FDA 510(k) premarket notification submitted by Medgyn Products, Inc. for the device "LAMINARIA". The FDA issued a decision of Substantially Equivalent on May 6, 1988. The device falls under product code HDY (Dilator, Cervical, Hygroscopic-Laminaria), a Class II device regulated under 21 CFR 884.4260. Medgyn Products, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 1988
Date Received
January 26, 1988
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 by Medgyn Products, Inc.

  • K143669 — MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini IUI (November 23, 2015)
  • K122973 — AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE (June 12, 2013)
  • K945179 — BOTTLE COLLECTION SET (January 26, 1995)
  • K880195 — GYNESCOPE (March 14, 1988)

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)
  • K955072 — LAMINARIA (May 22, 1996)
  • K892220 — LAMINARIA TENT (June 14, 1989)
  • K881295 — LAMINARIA CUREX (August 10, 1988)
  • K881312 — LAMINARIA (May 23, 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