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510(k) K961986

MANAN D BAG by Manan Medical Products, Inc. — Product Code EXF

K961986 is an FDA 510(k) premarket notification submitted by Manan Medical Products, Inc. for the device "MANAN D BAG". The FDA issued a decision of Substantially Equivalent on March 13, 1997. The device falls under product code EXF (Bag, Bile Collecting), a Class II device regulated under 21 CFR 876.5010. Manan Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 1997
Date Received
May 21, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bag, Bile Collecting
Device Class
Class II
Regulation Number
876.5010
Review Panel
GU
Submission Type

Other clearances by Manan Medical Products, Inc.

  • K052802 — MANAN BIO-CUT SOFT TISSUE BIOPSY NEEDLE (November 1, 2005)
  • K011209 — MANAN SPRITACRE SPINAL NEEDLES (June 26, 2001)
  • K983620 — MANAN SPINAL NEEDLES (January 8, 1999)
  • K980536 — EPIDURAL NEEDLE (July 31, 1998)
  • K981386 — MANAN BLUNT NEEDLE (June 29, 1998)
  • K980211 — MRI CHIBA,SPINAL,BREAST LOCALIZATION,AUTOMATIC CUTTING NEEDLES (February 6, 1998)
  • K974446 — MANAN AUTOMATIC CUTTING NEEDLE (January 8, 1998)
  • K962977 — MRI COMPATIBLE BIOPSY NEEDLES (October 9, 1997)
  • K963767 — MANAN V.S. ACCESS NEEDLE/SET (May 16, 1997)
  • K962001 — MANAN PEDIATRIC BONE MARROW ACCESS NEEDLE (January 10, 1997)

Other clearances for product code EXF

  • K003078 — MERIT DRAINAGE DEPOT (December 11, 2000)
  • K990428 — DRAINAGE BAG (August 12, 1999)
  • K980005 — MANAN D BAG (January 30, 1998)
  • K963849 — MANAN D BAG (December 13, 1996)
  • K943663 — NAVARRE 600 ML DRAINAGE BAG (September 8, 1994)
  • K911129 — MMG BILE BAG (August 7, 1991)
  • K903449 — URESIL TRU-CLOSE MULTI-PURPOSE DRAINAGE SET (September 12, 1990)
  • K901844 — URESIL TRU-CLOSE DRAINAGE BAG (June 1, 1990)

FDA data resources