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Unifine Pentips Plus

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K152339

by Owen Mumford Ltd

Identifiers

510(k) Number
K152339 FDA 510(k)
FDA Product Code
FMI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5570 FDA 510(k)
Regulation Number
880.5570 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Unifine Pentips Plus is a surgical needle holder (Device Type: FMI – Needle Holder, Forceps, or Scissors) designed for precise grasping and manipulation of suturing needles during surgical procedures. Its ergonomic design and sharp, atraumatic jaws facilitate controlled handling, reducing tissue trauma and improving suture accuracy in general hospital settings.

Supplied sterile and intended for single-use, the device is manufactured by Owen Mumford Ltd. and complies with FDA 510(k) clearance (K152339) under the Traditional pathway, classified as Substantially Equivalent (SESE) to predicate devices. It is regulated under the Medical Device Regulation (MDR) and distributed in sterile packaging for immediate clinical use, ensuring compliance with surgical standards.

Frequently asked questions

What types of surgical procedures is the Unifine Pentips Plus designed to assist with, and why is its ergonomic design important in those settings?

The Unifine Pentips Plus is designed for general hospital surgical procedures, specifically for precise grasping and manipulation of suturing needles. Its ergonomic design reduces hand fatigue and improves control during prolonged use, which is critical in delicate procedures like suturing where accuracy and atraumatic handling are essential to minimize tissue damage and ensure clean, secure stitches.

Is the Unifine Pentips Plus reusable, or is it intended for single-use only? How does this affect its clinical use?

The Unifine Pentips Plus is supplied sterile and explicitly intended for single-use only, as stated in the manufacturer’s instructions. This design choice ensures infection control and hygiene standards are maintained in surgical settings, eliminating the risk of cross-contamination that could arise from reprocessing reusable instruments.

What packaging does the Unifine Pentips Plus come in, and how does this relate to its readiness for immediate clinical use?

The Unifine Pentips Plus is distributed in sterile packaging, which is designed for immediate clinical use without additional sterilization steps. This ensures the device is ready to be opened and used right out of the box, reducing preparation time and maintaining sterility—critical factors in operating room workflows.

Are there different sizes or models of the Unifine Pentips Plus, and if so, how might a clinician choose between them?

The provided data does not specify distinct sizes or models beyond the Unifine Pentips Plus designation, which implies a standardized design for general hospital use. Since it is classified under FMI (Needle Holder, Forceps, or Scissors), clinicians would typically select based on ergonomic preference and compatibility with their surgical technique rather than varying sizes, as the focus is on precision and atraumatic needle handling.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Owen Mumford Ltd
FDA Applicant
Owen Mumford, Ltd.

Sources (2)

  • FDA 510(k) K152339 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026