FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

STYLET AND TRACHEAL LIGHTWAND (STL)

K Number: K922842 · Decision Dec 18, 1992
Classifications
1
FEI Numbers
133
Registration Numbers
133
Same Product Code
31
Applicant Total
5
Review Days
189

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Basic Information

Device Name
STYLET AND TRACHEAL LIGHTWAND (STL)
K Number
K922842
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
868.5790
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Laerdal California, Inc.
Date Received
June 12, 1992
Decision Date
December 18, 1992
Product Code
BSR
Advisory Committee
Anesthesiology
Review Advisory Committee
AN
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
BSR Stylet, Tracheal Tube

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (BSR), ordered by most recent decision date.

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Other Clearances by Laerdal California, Inc.

K Number Device Name
K941578 STATVAC PORTABLE SUCTION UNIT
K862875 E-VAC(TM)
K843790 TRACHEAL TUBE FIXATION DEVICE
K832990 STIFNICK IMMOBILIZING COLLAR