510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K932700Substantially Equivalent

Cuto(tm) Tissue Morcellation System

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

K932700 is the FDA 510(k) clearance record for CUTO(TM) TISSUE MORCELLATION SYSTEM, a class I device, cleared for Linvatec Corp. on under FDA product code GEY (Motor, Surgical Instrument, Ac-Powered). FDA records list 93 510(k) clearances for Linvatec Corp., from to . As of , FDA records show no recalls naming K932700.

Clearance record

Decision date
Received
(134 days to decision)
Product code
GEY Motor, Surgical Instrument, Ac-Powered
Regulation
21 CFR 878.4820
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Linvatec Corp. 11311 Concept Blvd., Largo FL
510(k) summary
Statement
Third party review
No

Clearances, product code GEY

Trailing 12 months

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

FDA records show no clearances under product code GEY in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GEY, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260