Home / 510(k) Clearances / K071663

510(k) K071663

VF GEL PLUS by Coapt Systems, Inc. — Product Code MIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 2008
Date Received
June 18, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Vocal Cord Medialization
Device Class
Class II
Regulation Number
874.3620
Review Panel
EN
Submission Type

Other clearances by Coapt Systems, Inc.

  • K083783 — VF LIQUIGEL (September 11, 2009)
  • K080956 — MODIFICATION TO VF GEL PLUS (April 25, 2008)
  • K060248 — ULTRATINE TRANSBLEPH (June 12, 2006)
  • K060249 — ULTRATINE FOREHEAD (June 12, 2006)
  • K060828 — MODIFICATION TO ENDOTINE RIBBON (April 19, 2006)
  • K051415 — ENDOTINE RIBBON (June 23, 2005)
  • K050611 — ENDOTINE RIBBON (April 6, 2005)
  • K042796 — ENDOTINE TRANSBLEPH 3.0/3.5 DEVICE (November 5, 2004)
  • K041835 — ENDOTINE MIDFACE B 4.5 DEVICE (September 28, 2004)
  • K042078 — ENDOTINE FOREHEAD TRIPLE DEVICE (August 27, 2004)

Other clearances for product code MIX

  • K240919 — Silk Voice (SMI-04) (May 3, 2024)
  • K180631 — Silk Voice (November 8, 2018)
  • K150400 — Renu Gel (April 6, 2015)
  • K121795 — CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT (February 22, 2013)
  • K083783 — VF LIQUIGEL (September 11, 2009)
  • K081815 — VOCALIS GEL (January 5, 2009)
  • K081816 — VOCALIS AND VOCALIS SM (January 5, 2009)
  • K080956 — MODIFICATION TO VF GEL PLUS (April 25, 2008)
  • K070090 — RADIESSE LARYNGEAL IMPLANT (March 1, 2007)
  • K060815 — JULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANT (April 18, 2006)