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510(k) K882013

SOFT TISSUE BIOPSY DEVICE by Ocean Medical Products, Ltd. — Product Code DWO

K882013 is an FDA 510(k) premarket notification submitted by Ocean Medical Products, Ltd. for the device "SOFT TISSUE BIOPSY DEVICE". The FDA issued a decision of Substantially Equivalent on June 15, 1988. The device falls under product code DWO (Needle, Biopsy, Cardiovascular), a Class I device regulated under 21 CFR 878.4800. Ocean Medical Products, Ltd. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 1988
Date Received
May 13, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Biopsy, Cardiovascular
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Ocean Medical Products, Ltd.

  • K870896 — NOTCH-NEEDLE, WESCOTT STYLE (March 18, 1987)
  • K843719 — SINGLE WALL INTRODUCER NEEDLE (October 18, 1984)
  • K823693 — MYELOGRAPHY NEEDLE (February 7, 1983)
  • K823692 — SPINAL NEEDLE (January 7, 1983)
  • K813462 — MADAYAG TYPE NEEDLE (March 1, 1982)
  • K813460 — CHIBA SKINNY NEEDLE (January 7, 1982)
  • K813448 — POTTS-COURNAND STYLE NEEDLE (January 7, 1982)
  • K813461 — PERCUTANEOUS ENTRY NEEDLE, SELDINGER (December 29, 1981)

Other clearances for product code DWO

  • K933364 — PROMED BIOPSY NEEDLE (February 15, 1994)
  • K921418 — ULTRA-CORE BIOPSY NEEDLES (June 19, 1992)
  • K913815 — AUTOMATED BIOPSY DEVICE, MODIFICATION (October 30, 1991)
  • K890925 — MANAN BONE MARROW BIOPSY NEEDLE (April 11, 1989)
  • K885145 — MEDSURG GREENE NEEDLE (March 14, 1989)
  • K885149 — NEEDLE INSERT FOR SOFT TISSUE BIOPSY DEVICE (January 26, 1989)
  • K874585 — ANGIOMED OSTY-CUT BONE BIOPSY NEEDLE (December 2, 1987)
  • K872597 — FINE NEEDLE ASPIRATION BIOPSY SYSTEM-PROSTATE (July 28, 1987)
  • K853312 — ARGON CUT BIOPSY NEEDLES, VARIOUS SIZES (September 12, 1985)
  • K820269 — RNG SERIES ULTRASOUND NEEDLE/CATH. GDS (March 23, 1982)

FDA data resources