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510(k) K884810

SILICONE LARYNGEAL STENT by Hood Laboratories — Product Code FWN

K884810 is an FDA 510(k) premarket notification submitted by Hood Laboratories for the device "SILICONE LARYNGEAL STENT". The FDA issued a decision of Substantially Equivalent on May 10, 1989. The device falls under product code FWN (Prosthesis, Larynx (Stents And Keels)), a Class II device regulated under 21 CFR 874.3620. Hood Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 1989
Date Received
November 17, 1988
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 Hood Laboratories

  • K921452 — ACOUSTIC RHINOMETER (July 8, 1993)
  • K920994 — HOOD NASAL SEPTAL BUTTON (May 15, 1992)
  • K905703 — KRUPIN EYE VALVE WITH DISK (March 15, 1991)
  • K904821 — ELIACHAR MODIFIED ESOPHAGEAL STENT (January 14, 1991)
  • K897049 — GIBSON ENDOLYMPHATIC SHUNT (March 16, 1990)
  • K897059 — HOOD SPEAKING VALVE (March 12, 1990)
  • K893866 — HOOD PEDIATRIC TRACHEOSTOMY TUBE (August 7, 1989)
  • K890599 — HOOD NASAL SPLINT (March 17, 1989)
  • K885125 — KRUPIN EYE VALVE W/SCLERAL BUCKLE (January 24, 1989)
  • K882430 — HOOD TRACHEAL STOMA BUTTON (June 28, 1988)

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)
  • 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