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510(k) K922842

STYLET AND TRACHEAL LIGHTWAND (STL) by Laerdal California, Inc. — Product Code BSR

K922842 is an FDA 510(k) premarket notification submitted by Laerdal California, Inc. for the device "STYLET AND TRACHEAL LIGHTWAND (STL)". The FDA issued a decision of Substantially Equivalent on December 18, 1992. The device falls under product code BSR (Stylet, Tracheal Tube), a Class I device regulated under 21 CFR 868.5790. Laerdal California, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1992
Date Received
June 12, 1992
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 Laerdal California, Inc.

  • K941578 — STATVAC PORTABLE SUCTION UNIT (May 18, 1994)
  • K862875 — E-VAC(TM) (November 3, 1986)
  • K843790 — TRACHEAL TUBE FIXATION DEVICE (March 11, 1985)
  • K832990 — STIFNICK IMMOBILIZING COLLAR (November 7, 1983)

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