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510(k) K852428

MANAN EPIDURAL NEEDLE by Manan Manufacturing Co., Inc. — Product Code GCB

K852428 is an FDA 510(k) premarket notification submitted by Manan Manufacturing Co., Inc. for the device "MANAN EPIDURAL NEEDLE". The FDA issued a decision of Substantially Equivalent on June 27, 1985. The device falls under product code GCB (Needle, Catheter), a Class I device regulated under 21 CFR 878.4200. Manan Manufacturing Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 1985
Date Received
June 7, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Catheter
Device Class
Class I
Regulation Number
878.4200
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)
  • K863848 — MANAN BREST TUMOR LOCALIZATION NEEDLE (October 14, 1986)
  • K851832 — NAMAN POTTS COURNAND NEEDLE (July 11, 1985)
  • K852501 — MYELOGRAM PROCEDURE TRAY (July 11, 1985)
  • K852018 — ARTHROGRAM TRAY FOR DOUBLE & SINGLE CONTRAST ARTHR (July 11, 1985)
  • K851833 — MANAN SELDINGER NEEDLE (July 11, 1985)
  • K851834 — MANAN GWI GUIDE WIRE INTRODUCER (July 11, 1985)
  • K852426 — MANAN TROCAR STYLE BIOPSY NEEDLE (June 27, 1985)
  • K852427 — MANAN SPINAL NEEDLE (June 27, 1985)

Other clearances for product code GCB

  • K150800 — Valved Safety Centesis Catheter (November 12, 2015)
  • K974146 — PARACENTESIS CATHETER DEVICE (January 28, 1998)
  • K930568 — ADAIR/VERESS NEEDLE INTRODUCER SET (July 22, 1993)
  • K923028 — TURKEL PNEUMOTHORAX KIT (August 4, 1992)
  • K900374 — ADAIR/VERESS NEEDLE INTRODUCER SET (April 20, 1990)
  • K854327 — SUBCUTANEOUS TUNNELING NEEDLES & HANDLES (November 13, 1985)
  • K780896 — NEEDLES, DESIGN CHANGE, IV CATHETERS (August 23, 1978)

FDA data resources