510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K952266Substantially Equivalent

Schroeder Oral/nasal Directional Stylette

Stebar Instrument Corp., Grand Rapids MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K952266 is the FDA 510(k) clearance record for SCHROEDER ORAL/NASAL DIRECTIONAL STYLETTE, a class I device, cleared for Stebar Instrument Corp. on under FDA product code BSR (Stylet, Tracheal Tube). FDA records list 2 510(k) clearances for Stebar Instrument Corp., from to . As of , FDA records show no recalls naming K952266.

Clearance record

Decision date
Received
(28 days to decision)
Product code
BSR Stylet, Tracheal Tube
Regulation
21 CFR 868.5790
Device class
Class I
Review panel
Anesthesiology
Applicant
Stebar Instrument Corp. 3066 Three Mile Rd., NW, Grand Rapids MI
510(k) summary
Statement
Third party review
No

Clearances, product code BSR

Trailing 12 months

FDA records hold no clearances under product code BSR in the trailing twelve months.

FDA records show no clearances under product code BSR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BSR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260