510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K973744Substantially Equivalent

Unicath Sp Bi-Plane (Model M269 & M289)

Xre Corp., Littleton MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K973744 is the FDA 510(k) clearance record for UNICATH SP BI-PLANE (MODEL M269 & M289), a class II device, cleared for Xre Corp. on under FDA product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified). FDA records list 19 510(k) clearances for Xre Corp., from to . As of , FDA records show no recalls naming K973744.

Clearance record

Decision date
Received
(89 days to decision)
Product code
JAA System, X-Ray, Fluoroscopic, Image-Intensified
Regulation
21 CFR 892.1650
Device class
Class II
Review panel
Radiology
Applicant
Xre Corp. 300 Foster St., Littleton MA
510(k) summary
Statement
Third party review
No

Clearances, product code JAA

Trailing 12 months
1 clearance under product code JAA in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JAA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260