510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011321Substantially Equivalent

Modification to Xps 3000 System

Medtronic Xomed, Inc., Jacksonville FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011321 is the FDA 510(k) clearance record for MODIFICATION TO XPS 3000 SYSTEM, a class II device, cleared for Medtronic Xomed, Inc. on under FDA product code ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece). FDA records list 46 510(k) clearances for Medtronic Xomed, Inc., from to . As of , FDA records show no recalls naming K011321.

Clearance record

Decision date
Received
(60 days to decision)
Product code
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Regulation
21 CFR 874.4250
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Medtronic Xomed, Inc. 6743 Southpoint Dr. N., Jacksonville FL
510(k) summary
Summary
Third party review
No

Clearances, product code ERL

Trailing 12 months

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

FDA records show no clearances under product code ERL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ERL, 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