510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K830058Substantially Equivalent

Myograph 2000

Prothia USA, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K830058 is the FDA 510(k) clearance record for MYOGRAPH 2000, a class II device, cleared for Prothia USA, Inc. on under FDA product code BXN (Stimulator, Nerve, Battery-Powered). FDA records list 5 510(k) clearances for Prothia USA, Inc., from to . As of , FDA records show no recalls naming K830058.

Clearance record

Decision date
Received
(59 days to decision)
Product code
BXN Stimulator, Nerve, Battery-Powered
Regulation
21 CFR 868.2775
Device class
Class II
Review panel
Anesthesiology
Applicant
Prothia USA, Inc. 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