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510(k) K892220

LAMINARIA TENT by Berkeley Medevices — Product Code HDY

K892220 is an FDA 510(k) premarket notification submitted by Berkeley Medevices for the device "LAMINARIA TENT". The FDA issued a decision of Substantially Equivalent on June 14, 1989. The device falls under product code HDY (Dilator, Cervical, Hygroscopic-Laminaria), a Class II device regulated under 21 CFR 884.4260. Berkeley Medevices has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 1989
Date Received
April 3, 1989
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 Berkeley Medevices

  • K840952 — MEDEVICE V-80 VACUUM PUMP (March 30, 1984)
  • K823006 — MEDEVICES ASPIRATION HOSE (November 4, 1982)
  • K812388 — SURGICAL PAWS (November 16, 1981)
  • K812389 — SURGICAL LOOPS (November 16, 1981)

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)
  • 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