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510(k) K955439

THE REEL THING (MODIFICATION) by Biomedical Devices, Inc. — Product Code GBX

K955439 is an FDA 510(k) premarket notification submitted by Biomedical Devices, Inc. for the device "THE REEL THING (MODIFICATION)". The FDA issued a decision of Substantially Equivalent on December 26, 1995. The device falls under product code GBX (Catheter, Irrigation), a Class I device regulated under 21 CFR 878.4200. Biomedical Devices, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 26, 1995
Date Received
November 13, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Irrigation
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

Other clearances by Biomedical Devices, Inc.

  • K931847 — BIO-PREP CEMENT RESTRICTOR (June 28, 1994)
  • K931846 — BIO-PREP (January 21, 1994)
  • K925982 — BMD AIR/OXYGEN BLENDER (October 7, 1993)
  • K903533 — STERI-SHIELD (October 19, 1990)
  • K902677 — STERI-SHIELD (August 17, 1990)
  • K830605 — PUMP PALL AMBULATORY INSULIN INFUSION (March 31, 1983)

Other clearances for product code GBX

  • K131659 — MOERAE VEIN PREPARATION KIT (March 3, 2014)
  • K082725 — GRAFTGUARD PRESSURE CONTROLLING SYRINGE (December 17, 2008)
  • K052286 — DEUTSCH ANTI-BLOCKAGE WOUND DRAIN (October 21, 2005)
  • K043515 — GRAFTSAVER (March 31, 2005)
  • K013417 — MISONIX IRRIGATION SYSTEM MOEDL BC20P (January 10, 2002)
  • K000704 — DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS) (May 19, 2000)
  • K974233 — LYSONIX IRRIGATION SYSTEM (February 3, 1998)
  • K973703 — JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAIN (December 4, 1997)
  • K972635 — ULTRACELL SUCTION SPONGE (October 1, 1997)
  • K965146 — FLAT CLOSED WOUND DRAIN WITH TROCAR (March 10, 1997)

FDA data resources