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510(k) K080956

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

K080956 is an FDA 510(k) premarket notification submitted by Coapt Systems, Inc. for the device "MODIFICATION TO VF GEL PLUS". The FDA issued a decision of Substantially Equivalent on April 25, 2008. The device falls under product code MIX (System, Vocal Cord Medialization), a Class II device regulated under 21 CFR 874.3620. Coapt Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 2008
Date Received
April 3, 2008
Clearance Type
Special
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)
  • K071663 — VF GEL PLUS (February 15, 2008)
  • K060249 — ULTRATINE FOREHEAD (June 12, 2006)
  • K060248 — ULTRATINE TRANSBLEPH (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)
  • K071663 — VF GEL PLUS (February 15, 2008)
  • K070090 — RADIESSE LARYNGEAL IMPLANT (March 1, 2007)
  • K060815 — JULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANT (April 18, 2006)

FDA data resources