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510(k) K940156

THE REEL THING by Bio-Medical Devices, Inc. — Product Code GBX

K940156 is an FDA 510(k) premarket notification submitted by Bio-Medical Devices, Inc. for the device "THE REEL THING". The FDA issued a decision of Substantially Equivalent on June 7, 1994. The device falls under product code GBX (Catheter, Irrigation), a Class I device regulated under 21 CFR 878.4200. Bio-Medical Devices, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 1994
Date Received
January 12, 1994
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 Bio-Medical Devices, Inc.

  • K040485 — MAXAIR SURGICAL HELMET SYSTEM (October 18, 2004)
  • K981888 — SMOKE-EVAC (October 15, 1998)
  • K955151 — MAXI-FLOW SUCTION TUBE/TOP GUN SUCTION IRRIGATOR (January 24, 1996)
  • K955149 — MAXI-FLOW SUCTION HANDLE/THE REEL THING TUBING REEL (January 24, 1996)
  • K955150 — MAXI-FLOW (January 23, 1996)
  • K933742 — TOP GUN (April 7, 1994)

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