510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K132097Substantially Equivalent

Best Multi-Lumen Balloon Applicator for Brachytherapy

Best Medical International, Inc., Springfield VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K132097 is the FDA 510(k) clearance record for BEST MULTI-LUMEN BALLOON APPLICATOR FOR BRACHYTHERAPY, a class II device, cleared for Best Medical International, Inc. on under FDA product code JAQ (System, Applicator, Radionuclide, Remote-Controlled). FDA records list 6 510(k) clearances for Best Medical International, Inc., from to . As of , FDA records show no recalls naming K132097.

Clearance record

Decision date
Received
(84 days to decision)
Product code
JAQ System, Applicator, Radionuclide, Remote-Controlled
Regulation
21 CFR 892.5700
Device class
Class II
Review panel
Radiology
Applicant
Best Medical International, Inc. 7643 Fullerton Rd., Springfield VA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JAQ

Trailing 12 months
4 clearances under product code JAQ in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JAQ, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20261
August 20260
September 20260
October 20260