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510(k) K855141

ANGIOMED FINE NEEDLES AND NEEDLE SET by Angiomed U.S., Inc. — Product Code GAA

K855141 is an FDA 510(k) premarket notification submitted by Angiomed U.S., Inc. for the device "ANGIOMED FINE NEEDLES AND NEEDLE SET". The FDA issued a decision of Substantially Equivalent on January 24, 1986. The device falls under product code GAA (Needle, Aspiration And Injection, Disposable), a Class I device regulated under 21 CFR 878.4800. Angiomed U.S., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1986
Date Received
December 26, 1985
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 Angiomed U.S., Inc.

  • K874771 — ANGIOMED INTRODUCING SETS (January 12, 1988)
  • K874585 — ANGIOMED OSTY-CUT BONE BIOPSY NEEDLE (December 2, 1987)
  • K864225 — ANGIOMED URETERAL D&M SETS/URETEROSCOPY GUID STENT (January 30, 1987)
  • K863386 — VESICO SUPRAPUBIC BLADDER DRAINAGE & EXCHANGE SETS (October 24, 1986)
  • K862805 — ANGIOMED VAC-U-CUT BIOPSY NEEDLE (September 29, 1986)
  • K863446 — ANGIOMED HIGH PRESSURE CONNECTORS (September 23, 1986)
  • K854910 — ANGIOFLOW (July 17, 1986)
  • K854912 — ANGIOMED GUIED WIRES (April 16, 1986)
  • K854908 — UROFLEX (March 14, 1986)
  • K855076 — ANGIOMED URETER DIATION SETS (March 11, 1986)

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