510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K954197Substantially Equivalent

Disposable Flex Tube

Engstrom Medical, S-161 02 Bromma, SE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954197 is the FDA 510(k) clearance record for DISPOSABLE FLEX TUBE, a class I device, cleared for Engstrom Medical on under FDA product code BZA (Connector, Airway (Extension)). FDA records list 2 510(k) clearances for Engstrom Medical, from to . As of , FDA records show no recalls naming K954197.

Clearance record

Decision date
Received
(50 days to decision)
Product code
BZA Connector, Airway (Extension)
Regulation
21 CFR 868.5810
Device class
Class I
Review panel
Anesthesiology
Applicant
Engstrom Medical Box 20109, S-161 02 Bromma, SE
510(k) summary
Summary
Third party review
No

Clearances, product code BZA

Trailing 12 months

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

FDA records show no clearances under product code BZA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BZA, 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