510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K960040Substantially Equivalent

Sharplan Ultra Laparoscopic Handpiece

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

K960040 is the FDA 510(k) clearance record for SHARPLAN ULTRA LAPAROSCOPIC HANDPIECE, 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 K960040.

Clearance record

Decision date
Received
(118 days to decision)
Product code
LFL Instrument, Ultrasonic Surgical
Device class
Unclassified
Review panel
Unknown
Applicant
Sharplan Lasers, Inc. 1 Pearl Ct., Allendale NJ
510(k) summary
Summary
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