510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K190006Substantially Equivalent

Magnetic Surgical System

Levita Magnetics International Corp., San Mateo CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K190006 is the FDA 510(k) clearance record for Magnetic Surgical System, a class II device, cleared for Levita Magnetics International Corp on under FDA product code PNL. FDA's definition for product code PNL reads: "System designed to grasp and retract the body and the fundus of the gallbladder in laparoscopic cholecystectomy procedures to facilitate access and visualization of the surgical site. The device is indicated for use in patients within a...". FDA records list 8 510(k) clearances for Levita Magnetics International Corp, from to . As of , FDA records show no recalls naming K190006.

Clearance record

Decision date
Received
(117 days to decision)
Product code
PNL Magnetic Surgical System
Regulation
21 CFR 878.4815
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Levita Magnetics International Corp 1730 S.Amphlett Blvd., Suite 240, San Mateo CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PNL

Trailing 12 months

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

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