510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K050343Substantially Equivalent

Reprocessed Harmonic Scalpels

Sterilmed Inc, Maple Grove MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K050343 is the FDA 510(k) clearance record for REPROCESSED HARMONIC SCALPELS, cleared for Sterilmed, Inc. on under FDA product code NLQ (Single-Use Reprocessed Ultrasonic Surgical Instruments). FDA's definition for product code NLQ reads: "Single-use reprocessed versions of the ultrasonic devices used in surgical procedures either for fragmentation, emulsification and aspiration of soft tissue and hard tissue or for ligation of vessels (under product code “LFL”)...". FDA records list 65 510(k) clearances for Sterilmed, Inc., from to . As of , FDA records show 2 recalls naming K050343.

Clearance record

Decision date
Received
(60 days to decision)
Product code
NLQ Single-Use Reprocessed Ultrasonic Surgical Instruments
Device class
Unclassified
Review panel
Unknown
Applicant
Sterilmed, Inc. 11400 73rd Ave. N Suite 100, Maple Grove MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NLQ

Trailing 12 months

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

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