Cleared Traditional

K032242 - PERSONNA PLUS SAFETY SCALPEL SYSTEM

K032242 is an FDA 510(k) clearance for PERSONNA PLUS SAFETY SCALPEL SYSTEM, manufactured by Omi Manufacturing Pty., Ltd.. The device is a Class 1 General & Plastic Surgery device with product code GES cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K032242 · Omi Manufacturing Pty., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2003
Decision
64d
Days
Class 1
Risk

K032242 is an FDA 510(k) clearance for the PERSONNA PLUS SAFETY SCALPEL SYSTEM. Classified as Blade, Scalpel (product code GES), Class I - General Controls.

Submitted by Omi Manufacturing Pty., Ltd. (Deer Field, US). The FDA issued a Cleared decision on September 23, 2003 after a review of 64 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K032242

510(k) Number K032242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2003
Decision Date September 23, 2003
Days to Decision 64 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 115d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

GES Device Classification - Class 1, General Controls

Product Code GES Blade, Scalpel
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Consultant

Underwriters Laboratories, Inc.

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GES Blade, Scalpel

All 27
Devices cleared under the same product code (GES) and FDA review panel - the closest regulatory comparables to K032242.
EASY-ON
K932998 · Devon Industries, Inc. · Aug 1993
LOS ALAMOS RETRACTABLE KNIFE
K923170 · Innovative Surgical Technology, Inc. · Feb 1993
SCALPEL BLADE REMOVER (BLADEGARD)
K915119 · Intergrated Visual, Inc. · May 1992
PRECISION GLIDE - ENHANCED SURGICAL BLADE
K911913 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1991
STERILE CARBON STEEL SURGICAL BLADE
K900266 · Rahn Laboratories · Mar 1990
ANCHOR DOUBLE-EDGE MYRINGOTOMY BLADE
K884862 · Anchor Products Co. · Dec 1988

FDA 510(k) Resources - General & Plastic Surgery

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K032242 · PERSONNA PLUS SAFETY SCALPEL SYSTEM
Download PDF FDA Summary Omi Manufacturing Pty…