510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K993885Substantially Equivalent

Ultrablator Electrode

Linvatec Corporation, Largo FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K993885 is the FDA 510(k) clearance record for ULTRABLATOR ELECTRODE, a class II device, cleared for Linvatec Corp. on under FDA product code JOS (Electrode, Electrosurgical). FDA records list 93 510(k) clearances for Linvatec Corp., from to . As of , FDA records show no recalls naming K993885.

Clearance record

Decision date
Received
(86 days to decision)
Product code
JOS Electrode, Electrosurgical
Regulation
21 CFR 878.4400
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Linvatec Corp. 11311 Concept Blvd., Largo FL
510(k) summary
Summary
Third party review
No

Clearances, product code JOS

Trailing 12 months

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

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