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510(k) K895285

MENTOR DUCTAL CATHETERS by Mentor Corp. — Product Code GBZ

K895285 is an FDA 510(k) premarket notification submitted by Mentor Corp. for the device "MENTOR DUCTAL CATHETERS". The FDA issued a decision of Substantially Equivalent on October 17, 1989. The device falls under product code GBZ (Catheter, Cholangiography), a Class I device regulated under 21 CFR 878.4200. Mentor Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 1989
Date Received
August 24, 1989
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 Mentor Corp.

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  • K053414 — MENTOR NOVASILK MESH (December 27, 2005)
  • K050008 — MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER (June 3, 2005)
  • K042851 — MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KIT (November 9, 2004)
  • K040959 — MENTOR GENESIS PENILE PROSTHESIS (October 29, 2004)
  • K031767 — MENTOR OBTAPE TRANS-OBTURATOR TAPE (July 17, 2003)
  • K011493 — MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRA (October 1, 2002)
  • K011500 — MENTOR CONTOUR PROFILE TISSUE EXPANDER (December 3, 2001)
  • K004005 — MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM (CURRENT), MENTOR CONTOUR GENES (October 12, 2001)
  • K010709 — MENTOR STERILE SALINE MAMMARY VOLUME SIZERS (April 23, 2001)

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)
  • K926143 — ANGIOLAPCATH CHOLANGIOGRAPHY KIT (July 7, 1993)
  • K924212 — STRYKER ENDOSCOPY CHOLANGIOGRAM KIT (July 7, 1993)
  • K925742 — CLARUS CHOLANGIOGRAM CATHETER KIT (June 1, 1993)
  • K924981 — OPERATIVE CHOLANGIOGRAM CATHETER (April 6, 1993)
  • K924480 — CHOLANGIOGRAPHY CLAMP (March 3, 1993)

FDA data resources