510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K884347Substantially Equivalent

Modified Disposable Coaxial Bipolar Pen

Advanced Surgical Products, Inc., Chesterfield MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K884347 is the FDA 510(k) clearance record for MODIFIED DISPOSABLE COAXIAL BIPOLAR PEN, a class II device, cleared for Advanced Surgical Products, Inc. on under FDA product code GXI (Probe, Radiofrequency Lesion). FDA records list 64 510(k) clearances for Advanced Surgical Products, Inc., from to . As of , FDA records show no recalls naming K884347.

Clearance record

Decision date
Received
(74 days to decision)
Product code
GXI Probe, Radiofrequency Lesion
Regulation
21 CFR 882.4725
Device class
Class II
Review panel
Neurology
Applicant
Advanced Surgical Products, Inc. 750 Goddard Ave., Chesterfield 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