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510(k) K121795

CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT by Cytophil, Inc. — Product Code MIX

K121795 is an FDA 510(k) premarket notification submitted by Cytophil, Inc. for the device "CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT". The FDA issued a decision of Substantially Equivalent on February 22, 2013. The device falls under product code MIX (System, Vocal Cord Medialization), a Class II device regulated under 21 CFR 874.3620. Cytophil, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 2013
Date Received
June 19, 2012
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 Cytophil, Inc.

  • K150400 — Renu Gel (April 6, 2015)
  • K102937 — OSTEOPHIL BETA-TCP (December 27, 2010)
  • K093871 — PERIOPHIL B-TCP (April 22, 2010)
  • K092788 — PERIOPHIL BIPHASIC (December 18, 2009)
  • K081816 — VOCALIS AND VOCALIS SM (January 5, 2009)
  • K081815 — VOCALIS GEL (January 5, 2009)
  • K072219 — CYTOPHIL TISSUE MARKER (January 18, 2008)

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)
  • 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)
  • K060815 — JULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANT (April 18, 2006)

FDA data resources