510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K950380Substantially Equivalent

Flextitip Stylette

Polamedco, Inc., Inglewood CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950380 is the FDA 510(k) clearance record for FLEXTITIP STYLETTE, a class I device, cleared for Polamedco, Inc. on under FDA product code BSR (Stylet, Tracheal Tube). FDA records list 20 510(k) clearances for Polamedco, Inc., from to . As of , FDA records show no recalls naming K950380.

Clearance record

Decision date
Received
(10 days to decision)
Product code
BSR Stylet, Tracheal Tube
Regulation
21 CFR 868.5790
Device class
Class I
Review panel
Anesthesiology
Applicant
Polamedco, Inc. 8295 A. Lacienega Blvd., Inglewood CA
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