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510(k) K990428

DRAINAGE BAG by Remington Medical, Inc. — Product Code EXF

K990428 is an FDA 510(k) premarket notification submitted by Remington Medical, Inc. for the device "DRAINAGE BAG". The FDA issued a decision of Substantially Equivalent on August 12, 1999. The device falls under product code EXF (Bag, Bile Collecting), a Class II device regulated under 21 CFR 876.5010. Remington Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1999
Date Received
February 11, 1999
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 Remington Medical, Inc.

  • K251904 — VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speake (November 20, 2025)
  • K241583 — VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charge (August 30, 2024)
  • K211589 — VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charge (January 27, 2022)
  • K212065 — VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charge (October 7, 2021)
  • K191315 — Remington Medical, Inc. Automatic Cutting Needle (NAC) (July 12, 2019)
  • K150266 — Remington Medical Inc. Tuohy Epidural Needles (June 4, 2015)
  • K130282 — REMINGTON MEDICAL CENTREFIRE 22 BIOPSY INSTRUMENT (May 13, 2013)
  • K050884 — ADAPTER CABLE (May 19, 2005)
  • K040266 — CORE NEEDLE BIOPSY (July 9, 2004)
  • K983621 — NEEDLE GUIDE (November 3, 1998)

Other clearances for product code EXF

  • K003078 — MERIT DRAINAGE DEPOT (December 11, 2000)
  • K980005 — MANAN D BAG (January 30, 1998)
  • K961986 — MANAN D BAG (March 13, 1997)
  • 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