510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K880293Substantially Equivalent

The Storz Bipolar Pencil and Cord

Storz Instrument Co., St. Louis MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K880293 is the FDA 510(k) clearance record for THE STORZ BIPOLAR PENCIL AND CORD, a class II device, cleared for Storz Instrument Co. on under FDA product code GXI (Probe, Radiofrequency Lesion). FDA records list 101 510(k) clearances for Storz Instrument Co., from to . As of , FDA records show no recalls naming K880293.

Clearance record

Decision date
Received
(52 days to decision)
Product code
GXI Probe, Radiofrequency Lesion
Regulation
21 CFR 882.4725
Device class
Class II
Review panel
Neurology
Applicant
Storz Instrument Co. 3365 Tree Ct. Industrial Blvd., St. Louis MO
Third party review
No

Clearances, product code GXI

Trailing 12 months
2 clearances under product code GXI in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GXI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260