510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K913848Substantially Equivalent

Sharplan Model Ultra Ultrasonic Surg Aspirator

Sharplan Lasers, Inc., Allendale NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K913848 is the FDA 510(k) clearance record for SHARPLAN MODEL ULTRA ULTRASONIC SURG ASPIRATOR, a class III device, cleared for Sharplan Lasers, Inc. on under FDA product code MGI (Aspirator, Ultrasonic). FDA records list 78 510(k) clearances for Sharplan Lasers, Inc., from to . As of , FDA records show no recalls naming K913848.

Clearance record

Decision date
Received
(213 days to decision)
Product code
MGI Aspirator, Ultrasonic
Device class
Class III
Review panel
Unknown
Applicant
Sharplan Lasers, Inc. 1 Pearl Ct., Allendale NJ
510(k) summary
Statement
Third party review
No

Clearances, product code MGI

Trailing 12 months

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

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