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510(k) K853940

THE GRONINGEN VOICE PROSTHESIS by Hood Laboratories — Product Code EWL

K853940 is an FDA 510(k) premarket notification submitted by Hood Laboratories for the device "THE GRONINGEN VOICE PROSTHESIS". The FDA issued a decision of Substantially Equivalent on December 13, 1985. The device falls under product code EWL (Prosthesis, Laryngeal (Taub)), a Class II device regulated under 21 CFR 874.3730. Hood Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 1985
Date Received
September 24, 1985
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

Other clearances by Hood Laboratories

  • K921452 — ACOUSTIC RHINOMETER (July 8, 1993)
  • K920994 — HOOD NASAL SEPTAL BUTTON (May 15, 1992)
  • K905703 — KRUPIN EYE VALVE WITH DISK (March 15, 1991)
  • K904821 — ELIACHAR MODIFIED ESOPHAGEAL STENT (January 14, 1991)
  • K897049 — GIBSON ENDOLYMPHATIC SHUNT (March 16, 1990)
  • K897059 — HOOD SPEAKING VALVE (March 12, 1990)
  • K893866 — HOOD PEDIATRIC TRACHEOSTOMY TUBE (August 7, 1989)
  • K884810 — SILICONE LARYNGEAL STENT (May 10, 1989)
  • K890599 — HOOD NASAL SPLINT (March 17, 1989)
  • K885125 — KRUPIN EYE VALVE W/SCLERAL BUCKLE (January 24, 1989)

Other clearances for product code EWL

  • K240763 — FirstFit Surgical Kit (December 18, 2024)
  • K141380 — PROVOX FREEHANDS FLEXIVOICE (September 26, 2014)
  • K131947 — PROVOX VEGA PUNCTURE SET (October 18, 2013)
  • K092593 — PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM) (October 14, 2010)
  • K093258 — BLOM-SINGER INDWELLING TEP OCCLUDER (March 3, 2010)
  • K090455 — PROVOX VEGA, MODEL 8130-8135 (June 5, 2009)
  • K082206 — BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-20 (September 4, 2008)
  • K043138 — PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134 (November 22, 2004)
  • K022125 — PROVOX FREEHANDS HME, MODEL 7710 (July 30, 2002)
  • K991587 — BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS (June 25, 1999)

FDA data resources