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FDA 510(k)

PERSONNA PLUS SAFETY SCALPEL SYSTEM

K-Number: K032242 · 2003-09-23

ApplicantOmi Manufacturing Pty., Ltd.
Decision Date2003-09-23
Product CodeGES
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PERSONNA PLUS SAFETY SCALPEL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Omi Manufacturing Pty., Ltd.. It received FDA 510(k) clearance on 2003-09-23 under 510(k) number K032242. The device is classified under product code GES. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERSONNA PLUS SAFETY SCALPEL SYSTEM?

PERSONNA PLUS SAFETY SCALPEL SYSTEM is a medical device that received FDA 510(k) clearance on 2003-09-23. The listed applicant is Omi Manufacturing Pty., Ltd.. The 510(k) number is K032242.

When did PERSONNA PLUS SAFETY SCALPEL SYSTEM receive FDA 510(k) clearance?

PERSONNA PLUS SAFETY SCALPEL SYSTEM received FDA 510(k) clearance on 2003-09-23, under 510(k) number K032242.

Who is the listed applicant for PERSONNA PLUS SAFETY SCALPEL SYSTEM?

The FDA 510(k) record lists Omi Manufacturing Pty., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PERSONNA PLUS SAFETY SCALPEL SYSTEM?

The FDA product code for PERSONNA PLUS SAFETY SCALPEL SYSTEM is GES.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Omi Manufacturing Pty., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K060971OMI RETRACTABLE SAFTEY SYRINGE, VARIOUS

Related Devices (Code: GES)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K932998EASY-ONDevon Industries, Inc.K923170LOS ALAMOS RETRACTABLE KNIFEInnovative Surgical Technology, Inc.K915119SCALPEL BLADE REMOVER (BLADEGARD)Intergrated Visual, Inc.K911913PRECISION GLIDE - ENHANCED SURGICAL BLADEBd Becton Dickinson Vacutainer Systems PreanalyticK900266STERILE CARBON STEEL SURGICAL BLADERahn LaboratoriesK884862ANCHOR DOUBLE-EDGE MYRINGOTOMY BLADEAnchor Products Co.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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