510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K150271Substantially Equivalent

Prime Adaptive Ultrasonic Scalpel System

Endoprime, Inc., Blue Ash OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K150271 is the FDA 510(k) clearance record for Prime Adaptive Ultrasonic Scalpel System, cleared for Endoprime, Inc. on under FDA product code LFL (Instrument, Ultrasonic Surgical). FDA records list one 510(k) clearance for Endoprime, Inc. As of , FDA records show no recalls naming K150271.

Clearance record

Decision date
Received
(114 days to decision)
Product code
LFL Instrument, Ultrasonic Surgical
Device class
Unclassified
Review panel
Unknown
Applicant
Endoprime, Inc. 4480 Lake Forest Dr., Suite 412, Blue Ash OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LFL

Trailing 12 months
1 clearance under product code LFL in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LFL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260