Instruments For Laparoscopy 5 Mm, 10 Mm With Coloured Handle, Detachable Endodc…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K003717 FDA 510(k)
- FDA Product Code
- GEI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4400 FDA 510(k)
- Regulation Number
- 878.4400 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
These instruments are laparoscopic tools designed for minimally invasive surgical procedures. They include detachable endoscopic components with 5 mm and 10 mm shafts, featuring coloured handles for improved visibility and ergonomic handling during laparoscopic interventions.
Supplied as reusable surgical instruments, they are intended for use in sterile operating environments. The devices are authorised under FDA 510(k) clearance (K003717) and comply with regulatory standards for general and plastic surgery applications. No single-use or MRI safety specifications are noted in the data.
Frequently asked questions
Are these laparoscopic instruments designed for single-use or can they be reused in multiple procedures?
These instruments are explicitly labeled as reusable surgical tools and must be sterilized between uses. Since they are intended for sterile operating environments, they are not single-use devices. Proper cleaning and sterilization protocols are required to maintain safety and functionality for repeated use in laparoscopic procedures.
What shaft sizes are available for these laparoscopic instruments, and how does the colored handle improve usability?
The instruments come in 5 mm and 10 mm shaft sizes, catering to different laparoscopic access ports and procedural needs. The colored handles enhance visibility and ergonomics, allowing surgeons to quickly distinguish between instruments during surgery and reduce fatigue by improving grip and control.
Do these instruments include detachable components, and if so, what is the purpose of this design?
Yes, these instruments feature detachable endoscopic components, including both the handle and shaft. This design allows for modularity—surgeons can swap or replace parts as needed, such as when transitioning between different procedures or when specific components require maintenance or sterilization. It also facilitates easier cleaning and storage.
What regulatory pathway was followed for FDA clearance of these laparoscopic instruments?
These instruments were cleared under the FDA 510(k) pathway (K003717), specifically through an Abbreviated 510(k) process, with a decision classification of Substantially Equivalent (SESE). The submission was reviewed by the General and Plastic Surgery (SU) Advisory Committee and filed under product code GEI, indicating compliance with regulatory standards for minimally invasive surgical tools.
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. Sources consulted: Instruments for Laparoscopy 5 Mm, 10 Mm With Coloured Handle ..., Laparoscopy - Endoservice Optical Instruments - PDF Catalogs ..., 100 Musical Instruments Names in English with Pictures, Deluxe Modular Instruments - Mediflex Surgical Products
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K003717 | Class II | Active |
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Manufacturer
- Manufacturer
- Tekno Medical Optik-Chirurgie GmbH & Co.
Sources (1)
- FDA 510(k) K003717 24 fields · synced Oct 6, 2026