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510(k) K924981

OPERATIVE CHOLANGIOGRAM CATHETER by Taut, Inc. — Product Code GBZ

K924981 is an FDA 510(k) premarket notification submitted by Taut, Inc. for the device "OPERATIVE CHOLANGIOGRAM CATHETER". The FDA issued a decision of Substantially Equivalent on April 6, 1993. The device falls under product code GBZ (Catheter, Cholangiography), 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
April 6, 1993
Date Received
October 1, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Cholangiography
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 GBZ

  • K973621 — PRE-VIEW CHOLANGIOGRAPHY CLAMP (December 17, 1997)
  • K944790 — FLEXIBLE LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER (November 29, 1994)
  • K942450 — ENDOPATH (August 5, 1994)
  • K932228 — MICROVASIVE INSURG CHLOANGIOGRAPHIC CATHETER (August 10, 1993)
  • K926217 — TERUMO ANGIOGRAPHIC CATHETER FOR LAPOROSCOPIC USE (July 13, 1993)
  • K924212 — STRYKER ENDOSCOPY CHOLANGIOGRAM KIT (July 7, 1993)
  • K926143 — ANGIOLAPCATH CHOLANGIOGRAPHY KIT (July 7, 1993)
  • K925742 — CLARUS CHOLANGIOGRAM CATHETER KIT (June 1, 1993)
  • K924480 — CHOLANGIOGRAPHY CLAMP (March 3, 1993)
  • K924128 — CHOLANGIOGRAPHY CATHETER (February 10, 1993)

FDA data resources