510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K032242Substantially Equivalent

Personna Plus Safety Scalpel System

Omi Manufacturing Pty., Ltd., Deer Field IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K032242 is the FDA 510(k) clearance record for PERSONNA PLUS SAFETY SCALPEL SYSTEM, a class I device, cleared for Omi Manufacturing Pty., Ltd. on under FDA product code GES (Blade, Scalpel). FDA records list 2 510(k) clearances for Omi Manufacturing Pty., Ltd., from to . As of , FDA records show no recalls naming K032242.

Clearance record

Decision date
Received
(64 days to decision)
Product code
GES Blade, Scalpel
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Omi Manufacturing Pty., Ltd. P.O. Box 7007, Deer Field IL
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code GES

Trailing 12 months

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

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