510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K981256Substantially Equivalent

Isolated Saline Electrodes/probes/devices-Salinetrode

Ximed/Prosure/Injectx, San Jose CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981256 is the FDA 510(k) clearance record for ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE, a class II device, cleared for Ximed/Prosure/Injectx on under FDA product code FAS (Electrode, Electrosurgical, Active, Urological). FDA records list 9 510(k) clearances for Ximed/Prosure/Injectx, from to . As of , FDA records show no recalls naming K981256.

Clearance record

Decision date
Received
(40 days to decision)
Product code
FAS Electrode, Electrosurgical, Active, Urological
Regulation
21 CFR 876.4300
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Ximed/Prosure/Injectx 2193 Trade Zone Blvd., San Jose CA
510(k) summary
Statement
Third party review
No

Clearances, product code FAS

Trailing 12 months
1 clearance under product code FAS 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 FAS, 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