510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K883091Substantially Equivalent

Sharplan 4300 & 4310 Ultrasonic Surgical Apirators

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

K883091 is the FDA 510(k) clearance record for SHARPLAN 4300 & 4310 ULTRASONIC SURGICAL APIRATORS, cleared for Sharplan Lasers, Inc. on under FDA product code LFL (Instrument, Ultrasonic Surgical). FDA records list 78 510(k) clearances for Sharplan Lasers, Inc., from to . As of , FDA records show no recalls naming K883091.

Clearance record

Decision date
Received
(84 days to decision)
Product code
LFL Instrument, Ultrasonic Surgical
Device class
Unclassified
Review panel
Unknown
Applicant
Sharplan Lasers, Inc. 1 Pearl Ct., Allendale NJ
Third party review
No

Clearances, product code LFL

Trailing 12 months
3 clearances under product code LFL in the twelve months to October 2026, October 2026 the highest month at 2.
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 20262