510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K971799Substantially Equivalent

Precision Flow Osv II

Elekta Implants, SA, Coral Gables FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971799 is the FDA 510(k) clearance record for PRECISION FLOW OSV II, a class II device, cleared for Elekta Implants, SA on under FDA product code JXG (Shunt, Central Nervous System And Components). FDA records list 2 510(k) clearances for Elekta Implants, SA, from to . As of , FDA records show no recalls naming K971799.

Clearance record

Decision date
Received
(267 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
Elekta Implants, SA 6011 Cellini St., Coral Gables FL
510(k) summary
Summary
Third party review
No

Clearances, product code JXG

Trailing 12 months
5 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 20261