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510(k) K870896

NOTCH-NEEDLE, WESCOTT STYLE by Ocean Medical Products, Ltd. — Product Code GAA

K870896 is an FDA 510(k) premarket notification submitted by Ocean Medical Products, Ltd. for the device "NOTCH-NEEDLE, WESCOTT STYLE". The FDA issued a decision of Substantially Equivalent on March 18, 1987. The device falls under product code GAA (Needle, Aspiration And Injection, Disposable), 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
March 18, 1987
Date Received
March 5, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Aspiration And Injection, Disposable
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Ocean Medical Products, Ltd.

  • K882013 — SOFT TISSUE BIOPSY DEVICE (June 15, 1988)
  • 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 GAA

  • K223625 — CapnoSpot™ Pneumothorax Decompression Indicator (March 28, 2023)
  • K102274 — ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENT (June 15, 2011)
  • K011586 — IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE (November 16, 2001)
  • K994151 — PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES (March 1, 2000)
  • K983200 — INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX (December 11, 1998)
  • K974741 — MANAN ACCURA NEEDLE (January 8, 1998)
  • K962425 — BONOPTY COAXIAL BONE BIOPSY SYSTEM WITH ECCENTRIC DRILL(10-1072,3,4) (September 11, 1996)
  • K961959 — MD TECH BIOPSY SET FOR BONE AND BONE MARROW (July 19, 1996)
  • K945109 — MONOJECT BONE MARROW BIOPSY TRAYS (November 14, 1994)
  • K940024 — MANAN GENERAL PURPOSE INTRODUCER NEEDLE (February 25, 1994)

FDA data resources