510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K142022Substantially Equivalent

Medline Renewal Reprocessed Gyrus-Diego Sinus Application Blades

Medline ReNewal, Redmond OR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K142022 is the FDA 510(k) clearance record for MEDLINE RENEWAL REPROCESSED GYRUS-DIEGO SINUS APPLICATION BLADES, a class I device, cleared for Medline Renewal on under FDA product code NLY (Microdebrider, Ent, High Speed, Single Use, Reprocessed). FDA's definition for product code NLY reads: "ENT microdebrider is an accessory to an ENT drill system. It is intended to remove soft and hard tissue during ear, nost and throat surgery. These devices operate at high speed for precise tissue resection. (this is for reprocessed sing...". FDA records list 24 510(k) clearances for Medline Renewal, from to . As of , FDA records show no recalls naming K142022.

Clearance record

Decision date
Received
(147 days to decision)
Product code
NLY Microdebrider, Ent, High Speed, Single Use, Reprocessed
Regulation
21 CFR 874.4140
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Medline Renewal 2747 SW 6th St., Redmond OR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NLY

Trailing 12 months

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

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