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510(k) K994151

PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES by Ximed/Prosure/Injectx — Product Code GAA

K994151 is an FDA 510(k) premarket notification submitted by Ximed/Prosure/Injectx for the device "PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES". The FDA issued a decision of Substantially Equivalent on March 1, 2000. The device falls under product code GAA (Needle, Aspiration And Injection, Disposable), a Class I device regulated under 21 CFR 878.4800. Ximed/Prosure/Injectx has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 2000
Date Received
December 9, 1999
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 Ximed/Prosure/Injectx

  • K002269 — ELECTROSURGICAL PROBES AND DEVICES-GELTX (January 4, 2001)
  • K983200 — INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX (December 11, 1998)
  • K983765 — INJECTION NEEDLE PROBE/DEVICE-TUNIS (December 11, 1998)
  • K981256 — ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE (May 12, 1998)
  • K974484 — ISOLATED ELECTROSURGICAL PROBES AND DEVICES-SALINETRODE (February 10, 1998)
  • K974637 — ELECTRODES/PROBES/DEVICES (January 7, 1998)
  • K962593 — ELECTROSURGICAL PROBES & DEVICES (November 12, 1996)
  • K945995 — BIPOLAR ELECTROSURGICAL PROBES AND INSTRUMENTS (January 31, 1995)

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)
  • 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)
  • K940025 — MANAN BONE MARROW HARVEST NEEDLES (February 25, 1994)

FDA data resources