510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K822137Substantially Equivalent

Digistim II

Beuro Technology, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K822137 is the FDA 510(k) clearance record for DIGISTIM II, a class II device, cleared for Beuro Technology on under FDA product code BXN (Stimulator, Nerve, Battery-Powered). FDA records list one 510(k) clearance for Beuro Technology. As of , FDA records show no recalls naming K822137.

Clearance record

Decision date
Received
(11 days to decision)
Product code
BXN Stimulator, Nerve, Battery-Powered
Regulation
21 CFR 868.2775
Device class
Class II
Review panel
Anesthesiology
Applicant
Beuro Technology 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code BXN

Trailing 12 months

FDA records hold no clearances under product code BXN in the trailing twelve months.

FDA records show no clearances under product code BXN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BXN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260