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510(k) K033398

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

K033398 is an FDA 510(k) premarket notification submitted by Bioform, Inc. for the device "LARYNGEAL AUGMENTATION IMPLANT". The FDA issued a decision of Substantially Equivalent on December 12, 2003. The device falls under product code MIX (System, Vocal Cord Medialization), a Class II device regulated under 21 CFR 874.3620. Bioform, Inc. has at least 3 other 510(k) clearances on record.

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)
  • K081815 — VOCALIS GEL (January 5, 2009)
  • K081816 — VOCALIS AND VOCALIS SM (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)

FDA data resources