510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K090584Substantially Equivalent

Intrabeam System with Balloon Applicator and Cbg Sets

Carl Zeiss Surgical GmbH, North Attleboro MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K090584 is the FDA 510(k) clearance record for INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS, a class II device, cleared for Carl Zeiss Surgical GmbH on under FDA product code JAD (System, Therapeutic, X-Ray). FDA records list 4 510(k) clearances for Carl Zeiss Surgical GmbH, from to . As of , FDA records show 5 recalls naming K090584.

Clearance record

Decision date
Received
(266 days to decision)
Product code
JAD System, Therapeutic, X-Ray
Regulation
21 CFR 892.5900
Device class
Class II
Review panel
Radiology
Applicant
Carl Zeiss Surgical GmbH 49 Plain St., North Attleboro MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JAD

Trailing 12 months
1 clearance under product code JAD in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JAD, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260