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510(k) K091135

RUTTER SUPRA STOMAL STENTS by Boston Medical Products, Inc. — Product Code FWN

K091135 is an FDA 510(k) premarket notification submitted by Boston Medical Products, Inc. for the device "RUTTER SUPRA STOMAL STENTS". The FDA issued a decision of Substantially Equivalent on September 14, 2009. The device falls under product code FWN (Prosthesis, Larynx (Stents And Keels)), a Class II device regulated under 21 CFR 874.3620. Boston Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2009
Date Received
April 20, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Larynx (Stents And Keels)
Device Class
Class II
Regulation Number
874.3620
Review Panel
EN
Submission Type

Other clearances by Boston Medical Products, Inc.

  • K972317 — MONTGOMERY THYROPLASTY IMPLANT SYSTEM (September 18, 1997)
  • K972459 — RHINOCELL NASAL PACKINGS (August 4, 1997)
  • K972096 — BIVALVE NASAL SPLINT (July 15, 1997)
  • K972078 — POST-STOP EPISTAXIS CATHETER (July 10, 1997)
  • K972092 — NASAL AIRWAY SPLINT (July 8, 1997)
  • K972151 — DOYLE COMBO NASAL AIRWAY SPLINT (July 7, 1997)
  • K972060 — NASAL SEPTAL BUTTON (July 3, 1997)
  • K972082 — CUSTOM NASAL SPLINT (July 3, 1997)
  • K972077 — EPI-STOP EPISTAXIS CATHETER (June 26, 1997)
  • K972076 — EPI-MAX EPISTAXIS CATHETER (June 26, 1997)

Other clearances for product code FWN

  • K000154 — ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1 (March 29, 2000)
  • K962693 — MONTGOMERY RADIOPAQUE LARYNGEAL KEEL (August 9, 1996)
  • K896667 — LORENZ STENT (February 22, 1990)
  • K884810 — SILICONE LARYNGEAL STENT (May 10, 1989)
  • K864936 — 'EXMOOR' DAS GUPTA LARYNGEAL KEEL (April 27, 1987)
  • K853726 — LARYNGEAL (March 12, 1986)
  • K842800 — MONTG. LARYNGEAL KEEL (August 2, 1984)
  • K842287 — MONTGOMERY LARYNGEAL STENT (June 27, 1984)
  • K841347 — LARYNGEAL STENT (May 2, 1984)

FDA data resources