510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K971511Substantially Equivalent

Radionics Contour Flex Valve, Radionics Contour Flex Plus Valve

Radionics, Inc., Burlington MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971511 is the FDA 510(k) clearance record for RADIONICS CONTOUR FLEX VALVE, RADIONICS CONTOUR FLEX PLUS VALVE, a class II device, cleared for Radionics, Inc. on under FDA product code JXG (Shunt, Central Nervous System And Components). FDA records list 57 510(k) clearances for Radionics, Inc., from to . As of , FDA records show no recalls naming K971511.

Clearance record

Decision date
Received
(87 days to decision)
Product code
JXG Shunt, Central Nervous System And Components
Regulation
21 CFR 882.5550
Device class
Class II
Review panel
Neurology
Applicant
Radionics, Inc. 76 Cambridge St., Burlington MA
510(k) summary
Summary
Third party review
No

Clearances, product code JXG

Trailing 12 months
4 clearances under product code JXG in the twelve months to October 2026, November 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code JXG, trailing twelve months
MonthClearances
November 20252
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260