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510(k) K845006

SUN MEDICAL LAMINARIA CERVICAL DILATOR by Sun Medical, Inc. — Product Code HDY

K845006 is an FDA 510(k) premarket notification submitted by Sun Medical, Inc. for the device "SUN MEDICAL LAMINARIA CERVICAL DILATOR". The FDA issued a decision of Substantially Equivalent on May 1, 1985. The device falls under product code HDY (Dilator, Cervical, Hygroscopic-Laminaria), a Class II device regulated under 21 CFR 884.4260. Sun Medical, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 1985
Date Received
December 26, 1984
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 Sun Medical, Inc.

  • K921963 — DISPOSABLE, FILTERED INSUFFLATION TUBING, 92-900 (September 11, 1992)
  • K911154 — SUN MEDICAL SMOKE/FLUID EVAC SYST, MODEL SFE-200 (July 26, 1991)
  • K874948 — SUN MEDICAL SMOKE EVACUATOR SYSTEM (February 18, 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)
  • K880196 — LAMINARIA (May 6, 1988)
  • K833068 — LAMINARIA JAPONICA CERVICAL DILATOR (February 4, 1984)
  • K782067 — DILATOR, MIZUTANI LAMINARIA TENT (January 3, 1979)

FDA data resources