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510(k) K933598

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

K933598 is an FDA 510(k) premarket notification submitted by Fiberoptic Medical Products, Inc. for the device "ENDOSTAR(TM) STYLET". The FDA issued a decision of Substantially Equivalent on January 25, 1994. The device falls under product code BSR (Stylet, Tracheal Tube), a Class I device regulated under 21 CFR 868.5790. Fiberoptic Medical Products, Inc. has at least 4 other 510(k) clearances on record.

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)

Other clearances for product code BSR

  • K162729 — Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exc (August 11, 2017)
  • K962361 — TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND (September 5, 1996)
  • 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)

FDA data resources