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510(k) K933598

ENDOSTAR(TM) STYLET by Fiberoptic Medical Products, Inc. — Product Code BSR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 1994
Date Received
July 26, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stylet, Tracheal Tube
Device Class
Class I
Regulation Number
868.5790
Review Panel
AN
Submission Type

Other clearances by Fiberoptic Medical Products, Inc.

  • K944686 — FIBEROPTIC LARYNGOSCOPE HANDLE (November 4, 1994)
  • K921393 — IMAGICA MICRO-ENDOSCOPE (August 20, 1992)
  • K912252 — INFINITY(R) TRANSILLUMINATOR EXAMINATION LIGHT (June 27, 1991)
  • K883779 — WALLABY(TM) BLANKET (November 14, 1988)

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  • K954771 — TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRA (May 9, 1996)
  • K943104 — MOLLOY INTUBATING STYLETTE (April 18, 1996)
  • K955238 — RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLE (February 6, 1996)
  • K953677 — LIGHTED FLEXGUIDE (MODIFICATION) (August 25, 1995)
  • K952100 — RUSCH ENDOTRACHEAL TUBE STYLET (August 8, 1995)
  • K952266 — SCHROEDER ORAL/NASAL DIRECTIONAL STYLETTE (June 12, 1995)
  • K950713 — AIRGUIDE STYLETTE (May 17, 1995)
  • K950380 — FLEXTITIP STYLETTE (February 10, 1995)