510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K945238Substantially Equivalent

Mavig Lower Body Protection Systems, Assembly Models 6265, 6266, 6267, 6268, 6269/0, 629/1, and 6269/2

F. Walter Hanel GmbH, North Attleboro MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K945238 is the FDA 510(k) clearance record for MAVIG LOWER BODY PROTECTION SYSTEMS, ASSEMBLY MODELS 6265, 6266, 6267, 6268, 6269/0, 629/1, AND 6269/2, a class I device, cleared for F. Walter Hanel GmbH on under FDA product code IWQ (Curtain, Protective, Radiographic). FDA records list 3 510(k) clearances for F. Walter Hanel GmbH, from to . As of , FDA records show no recalls naming K945238.

Clearance record

Decision date
Received
(49 days to decision)
Product code
IWQ Curtain, Protective, Radiographic
Regulation
21 CFR 892.6500
Device class
Class I
Review panel
Radiology
Applicant
F. Walter Hanel GmbH 49 Plain St., North Attleboro MA
510(k) summary
Summary
Third party review
No

Clearances, product code IWQ

Trailing 12 months

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

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