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
K081277Substantially Equivalent

Xps 4000 System, Midas Rex Legend Ehs System, Integrated Power Cons0le (Ipc)

Medtronic Xomed, Inc., Jacksonville FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081277 is the FDA 510(k) clearance record for XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC), 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 one recall naming K081277.

Clearance record

Decision date
Received
(123 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 PDF
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