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510(k) K863565

MENTOR ALLOPLASTIC SPERMATOCELE by Mentor Corp. — Product Code LQS

K863565 is an FDA 510(k) premarket notification submitted by Mentor Corp. for the device "MENTOR ALLOPLASTIC SPERMATOCELE". The FDA issued a decision of Substantially Equivalent on November 19, 1986. The device falls under product code LQS (Spermatocele, Alloplastic), a Class U device. Mentor Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 1986
Date Received
September 12, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spermatocele, Alloplastic
Device Class
Class U
Regulation Number
Review Panel
GU
Submission Type

Other clearances by Mentor Corp.

  • K130813 — MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TI (April 11, 2013)
  • 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)

FDA data resources