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510(k) K150400

Renu Gel by Cytophil, Inc. — Product Code MIX

K150400 is an FDA 510(k) premarket notification submitted by Cytophil, Inc. for the device "Renu Gel". The FDA issued a decision of Substantially Equivalent on April 6, 2015. 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
April 6, 2015
Date Received
February 18, 2015
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 Cytophil, Inc.

  • K121795 — CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT (February 22, 2013)
  • 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)
  • 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)
  • K060815 — JULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANT (April 18, 2006)

FDA data resources