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510(k) K863848

MANAN BREST TUMOR LOCALIZATION NEEDLE by Manan Manufacturing Co., Inc. — Product Code GAA

K863848 is an FDA 510(k) premarket notification submitted by Manan Manufacturing Co., Inc. for the device "MANAN BREST TUMOR LOCALIZATION NEEDLE". The FDA issued a decision of Substantially Equivalent on October 14, 1986. The device falls under product code GAA (Needle, Aspiration And Injection, Disposable), a Class I device regulated under 21 CFR 878.4800. Manan Manufacturing Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 1986
Date Received
September 30, 1986
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 Manan Manufacturing Co., Inc.

  • K873208 — MANAN TURNER STYLE NEEDLE (August 25, 1987)
  • K864405 — MANAN CONTRAST MEDIA ADMINISTRATION SET (December 18, 1986)
  • K851833 — MANAN SELDINGER NEEDLE (July 11, 1985)
  • K852501 — MYELOGRAM PROCEDURE TRAY (July 11, 1985)
  • K851832 — NAMAN POTTS COURNAND NEEDLE (July 11, 1985)
  • K852018 — ARTHROGRAM TRAY FOR DOUBLE & SINGLE CONTRAST ARTHR (July 11, 1985)
  • K851834 — MANAN GWI GUIDE WIRE INTRODUCER (July 11, 1985)
  • K852428 — MANAN EPIDURAL NEEDLE (June 27, 1985)
  • K852426 — MANAN TROCAR STYLE BIOPSY NEEDLE (June 27, 1985)
  • K852427 — MANAN SPINAL NEEDLE (June 27, 1985)

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