Discovery Pico, Discovery Pico Plus
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K171945 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Discovery Pico and Discovery Pico Plus are Powered Surgical Handpieces designed for precision cutting and drilling in orthopedic and plastic surgery procedures. These devices are engineered to deliver controlled rotational power for bone and tissue manipulation, enhancing surgical efficiency in procedures requiring fine motor control and accuracy.
These handpieces are supplied as reusable instruments, intended for use in sterile surgical environments. They are classified under the General, Plastic Surgery advisory committee category and comply with FDA 510(k) clearance and MDD directives. The Discovery Pico and Discovery Pico Plus are available in a single configuration, with no additional size variations specified, and require proper maintenance and sterilization between uses to ensure safety and performance.
Frequently asked questions
Are the Discovery Pico and Discovery Pico Plus handpieces designed for single-use or reusable in surgery?
The Discovery Pico and Discovery Pico Plus are reusable instruments, intended for use in sterile surgical environments. Since they are designed for repeated use, proper maintenance and sterilization between procedures are required to ensure safety and performance.
What types of surgical procedures are these handpieces primarily intended for?
These handpieces are engineered for orthopedic and plastic surgery procedures, specifically for precision cutting and drilling where controlled rotational power is needed. They are particularly useful in surgeries requiring fine motor control and accuracy, such as bone and tissue manipulation.
How are the Discovery Pico and Discovery Pico Plus supplied, and do they come in multiple sizes?
The handpieces are supplied as reusable instruments in a single configuration, with no additional size variations specified. They are intended for use in sterile surgical environments and require proper maintenance between uses.
What regulatory pathways have these devices followed for market authorization?
The Discovery Pico and Discovery Pico Plus have undergone FDA 510(k) clearance under the Traditional pathway and comply with MDD (Medical Device Directive) directives. They were classified under the General, Plastic Surgery advisory committee category (SU) and received a decision of Substantially Equivalent (SESE).
What maintenance or sterilization steps are necessary to ensure these handpieces remain safe and functional between uses?
Since these are reusable instruments, they must undergo proper maintenance and sterilization between uses to preserve safety and performance. The manufacturer’s guidelines (not detailed here) should be followed to ensure compliance with surgical standards.
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
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K171945 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Quanta System Spa
Sources (2)
- FDA 510(k) K171945 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026