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510(k) K915761

BIVONA-COLORADO VOICE PROSTHESIS by Bivona Medical Technologies — Product Code EWL

K915761 is an FDA 510(k) premarket notification submitted by Bivona Medical Technologies for the device "BIVONA-COLORADO VOICE PROSTHESIS". The FDA issued a decision of Substantially Equivalent on Jun 29, 1992. The device falls under product code EWL (Prosthesis, Laryngeal (Taub)), a Class II device regulated under 21 CFR 874.3730. Bivona Medical Technologies has 49 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Jun 29, 1992
Date Received
Dec 24, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Prosthesis, Laryngeal (Taub)
Device Class
Class II
Regulation Number
874.3730
Review Panel
EN
Submission Type
510(k)

Other clearances by Bivona Medical Technologies

  • K952700 — SUPERSLICK (Oct 31, 1995)
  • K942025 — BURGET NASAL STENT (Oct 27, 1995)
  • K944178 — BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES (Oct 27, 1994)
  • K935053 — BIVONA NASAL TURBINATE STENT (Jul 1, 1994)
  • K933398 — BIVONA ILLUMINATED ENDOTRACHEAL TUBE (Oct 6, 1993)
  • K931749 — BIVONA(R) ICU ENDOTRACHEAL TUBE (Aug 10, 1993)
  • K922665 — BIVONA HYPERFLEX TRACHEOSTOMY TUBE (Jan 7, 1993)
  • K923878 — BIVONA CUSTOMIZED TRACHEOSTOMY TUBES (Dec 29, 1992)
  • K920604 — BIVONA TRACHEAL T-TUBE STENT (Jul 27, 1992)
  • K915799 — BIVONA SLEEP APNEA TUBE (Feb 3, 1992)

Other clearances for product code EWL

  • K240763 — FirstFit Surgical Kit (Dec 18, 2024)
  • K141380 — PROVOX FREEHANDS FLEXIVOICE (Sep 26, 2014)
  • K131947 — PROVOX VEGA PUNCTURE SET (Oct 18, 2013)
  • K092593 — PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM) (Oct 14, 2010)
  • K093258 — BLOM-SINGER INDWELLING TEP OCCLUDER (Mar 3, 2010)
  • K090455 — PROVOX VEGA, MODEL 8130-8135 (Jun 5, 2009)
  • K082206 — BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES… (Sep 4, 2008)
  • K043138 — PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134 (Nov 22, 2004)
  • K022125 — PROVOX FREEHANDS HME, MODEL 7710 (Jul 30, 2002)
  • K991587 — BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS (Jun 25, 1999)

FDA data resources

Source: FDA 510(k) database entry for K915761. Report a data issue: hello@regdatalab.com.