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510(k) K771066

CATHETER, SAMPLING, CONDUIT by Mentor Corp. — Product Code FEZ

K771066 is an FDA 510(k) premarket notification submitted by Mentor Corp. for the device "CATHETER, SAMPLING, CONDUIT". The FDA issued a decision of Substantially Equivalent on July 11, 1977. The device falls under product code FEZ (Catheter And Tube, Suprapubic), a Class II device regulated under 21 CFR 876.5090. Mentor Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 1977
Date Received
June 13, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter And Tube, Suprapubic
Device Class
Class II
Regulation Number
876.5090
Review Panel
GU
Submission Type

Other clearances by Mentor Corp.

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  • 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)

FDA data resources