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510(k) K841347

LARYNGEAL STENT by E. Benson Hood Laboratories, Inc. — Product Code FWN

K841347 is an FDA 510(k) premarket notification submitted by E. Benson Hood Laboratories, Inc. for the device "LARYNGEAL STENT". The FDA issued a decision of Substantially Equivalent on May 2, 1984. The device falls under product code FWN (Prosthesis, Larynx (Stents And Keels)), a Class II device regulated under 21 CFR 874.3620. E. Benson Hood Laboratories, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 1984
Date Received
April 2, 1984
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 E. Benson Hood Laboratories, Inc.

  • K983878 — CZAJA-MCCAFFREY RIGID STENT INTRODUCER/ENDOSCOPE (January 29, 1999)
  • K841350 — SALIVARY BYPASS TUBE (July 26, 1984)
  • K841349 — ESOPHAGEAL TUBE (July 23, 1984)
  • K841266 — MONTGOMERY TRACHEAL T-TUBE (June 14, 1984)
  • K841348 — UMBRELLA KEEL (May 2, 1984)

Other clearances for product code FWN

  • K091135 — RUTTER SUPRA STOMAL STENTS (September 14, 2009)
  • 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)

FDA data resources