510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K103128Substantially Equivalent

Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip /Ball Tip Pedicle Screw Stimulator Probe,

Cadwell Lab, Inc., Kennewick WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K103128 is the FDA 510(k) clearance record for CADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH TIP /BALL TIP PEDICLE SCREW STIMULATOR PROBE,, a class II device, cleared for Cadwell Lab, Inc. on under FDA product code ETN (Stimulator, Nerve). FDA records list one 510(k) clearance for Cadwell Lab, Inc. As of , FDA records show no recalls naming K103128.

Clearance record

Decision date
Received
(121 days to decision)
Product code
ETN Stimulator, Nerve
Regulation
21 CFR 874.1820
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Cadwell Lab, Inc. 909 N Kellogg St., Kennewick WA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ETN

Trailing 12 months
2 clearances under product code ETN in the twelve months to October 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code ETN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20262
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260