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510(k) K131745

BLOM-SINGER SEPTAL PERFORATION PROSTHESIS by Helix Medical, LLC — Product Code LFB

K131745 is an FDA 510(k) premarket notification submitted by Helix Medical, LLC for the device "BLOM-SINGER SEPTAL PERFORATION PROSTHESIS". The FDA issued a decision of Substantially Equivalent on September 17, 2013. The device falls under product code LFB (Button, Nasal Septal), a Class U device. Helix Medical, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2013
Date Received
June 13, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Button, Nasal Septal
Device Class
Class U
Regulation Number
Review Panel
EN
Submission Type

Other clearances by Helix Medical, LLC

  • K130736 — BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS (December 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)
  • K930105 — BLOM-SINGER LOW PRESSURE VOICE PROSTHESIS,P.I.D.S. (May 17, 1993)

Other clearances for product code LFB

  • K013696 — SILMED NASAL SEPTAL BUTTON (November 28, 2001)
  • K982667 — MICROMEDICS NASAL SEPTAL BUTTON (November 24, 1998)
  • K972060 — NASAL SEPTAL BUTTON (July 3, 1997)
  • K920994 — HOOD NASAL SEPTAL BUTTON (May 15, 1992)
  • K901366 — INVOTEC SEPTAL BUTTON (June 14, 1990)
  • K871072 — OMEGA NASAL SEPTAL BUTTON (June 8, 1987)
  • K871200 — CUI NASAL SEPTUM BUTTON (April 15, 1987)
  • K862497 — MICROTEK SEPTAL BUTTON (July 14, 1986)
  • K850492 — NASAL SEPTAL BUTTON (March 7, 1985)
  • K822637 — NASAL SEPTAL BUTTONS (September 28, 1982)

FDA data resources