Home / 510(k) Clearances / K897005

510(k) K897005

BLOM-SINGER(R) SILICONE LARYNGECTOMY TUBE by Helix Medical, Inc. — Product Code JOH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 1990
Date Received
December 18, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube Tracheostomy And Tube Cuff
Device Class
Class II
Regulation Number
868.5800
Review Panel
AN
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)
  • K991587 — BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS (June 25, 1999)
  • 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)

Other clearances for product code JOH

  • K251313 — Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with (December 29, 2025)
  • K210833 — Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Trach (November 26, 2021)
  • K203362 — TRACOE vario (August 5, 2021)
  • K193077 — Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff (June 1, 2020)
  • K193133 — Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Mult (December 12, 2019)
  • K182861 — Shiley Neonatal/Pediatric Tracheostomy Tube (March 22, 2019)
  • K173912 — BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Perc (May 8, 2018)
  • K180034 — Weinmann Tracheostomy Exchange Set (May 7, 2018)
  • K172720 — TRACOE silcosoft Tracheostomy Tube (April 27, 2018)
  • K170720 — Portex Blue Line Ultra Paediatric Tracheosomy Tube (December 7, 2017)