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510(k) K033398

LARYNGEAL AUGMENTATION IMPLANT by Bioform, Inc. — Product Code MIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2003
Date Received
October 24, 2003
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 Bioform, Inc.

  • K030682 — CALCIUM HYDROXYLAPATITE IMPLANT, ICC AND 0.5CC, MODELS 8038-3, 8037-3 (June 27, 2003)
  • K013243 — COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0008021-1, 0008022-1 (January 9, 2002)
  • K012955 — COAPTITE TISSUE MARKER AND COAPTITE FN TISSUE MARKER (October 22, 2001)

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)
  • K081816 — VOCALIS AND VOCALIS SM (January 5, 2009)
  • K081815 — VOCALIS GEL (January 5, 2009)
  • K080956 — MODIFICATION TO VF GEL PLUS (April 25, 2008)
  • K071663 — VF GEL PLUS (February 15, 2008)
  • K070090 — RADIESSE LARYNGEAL IMPLANT (March 1, 2007)