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510(k) K991587

BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS by Helix Medical, Inc. — Product Code EWL

K991587 is an FDA 510(k) premarket notification submitted by Helix Medical, Inc. for the device "BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS". The FDA issued a decision of Substantially Equivalent on June 25, 1999. The device falls under product code EWL (Prosthesis, Laryngeal (Taub)), a Class II device regulated under 21 CFR 874.3730. Helix Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1999
Date Received
May 7, 1999
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 Helix Medical, Inc.

  • K130736 — BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS (December 17, 2013)
  • K131745 — BLOM-SINGER SEPTAL PERFORATION PROSTHESIS (September 17, 2013)
  • K093258 — BLOM-SINGER INDWELLING TEP OCCLUDER (March 3, 2010)
  • K082206 — BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-20 (September 4, 2008)
  • K023259 — INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200 (December 26, 2002)
  • K945287 — INHEALTH BLOM-SINGER INDWELLING VALVED INSERT ACCESSORY DEVICE (December 9, 1994)
  • K945288 — INHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICE (December 2, 1994)
  • K932120 — BLOM-SINGER INDWELLING LOW PRESSURE VOICE PROSTHES (April 15, 1994)
  • K932163 — BLOM-SINGER VOICE PROSTHESIS FLUSHING PIPET (December 15, 1993)
  • K930105 — BLOM-SINGER LOW PRESSURE VOICE PROSTHESIS,P.I.D.S. (May 17, 1993)

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)
  • K974132 — VOICE MASTER PROSTHESIS (February 25, 1998)

FDA data resources