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510(k) K921934

INTRADUCER by Taut, Inc. — Product Code GBX

K921934 is an FDA 510(k) premarket notification submitted by Taut, Inc. for the device "INTRADUCER". The FDA issued a decision of Substantially Equivalent on July 15, 1992. The device falls under product code GBX (Catheter, Irrigation), a Class I device regulated under 21 CFR 878.4200. Taut, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 1992
Date Received
April 24, 1992
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 Taut, Inc.

  • K023261 — ADAPT BALLOON OPEN ACCESS PORT, MODEL 41244 (December 13, 2002)
  • K021731 — ADAPT OPEN ACCESS PORT, MODEL 41233 (August 8, 2002)
  • K011018 — TAUT BALLOON CATHETER, MODEL 50640 (June 22, 2001)
  • K010007 — ADAPT LAPAROSCOPIC PORT & ADAPT REDUCER CAP (February 22, 2001)
  • K003703 — TAUT-INSUFFLATION NEEDLE (February 22, 2001)
  • K992904 — MINI-PORT (October 5, 1999)
  • K992907 — INTRADUCER (October 5, 1999)
  • K972112 — INTRADUCER PORT SC CATALOG#31275,31035,30915, AND 31450 (December 1, 1997)
  • K962003 — TUAT SPLATTER CONTROL SHIELD SCS-300 (July 18, 1996)
  • K960883 — INTRADUCER PERITONEAL CATHETER 6FRX3, 9FRX3 1/2, 10FRX4, 12FRX8 (March 20, 1996)

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