MaXcess
MaXcess Resector, Monopolar Disposable
1manufacturer
17catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Registered in Shandong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
Record
| Listed by | Nuvasive, Inc., United States |
|---|---|
| FDA product code | FST |
| Device type | Light, Surgical, Fiberoptic |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4580 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K042034 |
| Record published | 2019-11-21 |
| Record revised | 2026-05-18 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1025461 | In distribution | |
| 3500017 | In distribution | |
| 1025462 | In distribution | |
| 3241002 | In distribution | |
| 3241000 | In distribution | |
| 1200062 | In distribution | |
| 3200220 | In distribution | |
| 1577130 | In distribution | |
| 3200028 | In distribution | |
| 1564865 | In distribution | |
| 3400033 | In distribution | |
| 3210030 | In distribution | |
| 3200060 | In distribution | |
| 1010987 | In distribution | |
| 3240060 | In distribution | |
| 3200120 | In distribution | |
| 3400044 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| System TWO LED | Medical Illumination International, Inc | 109 |
| Vu | Medical Illumination International, Inc | 48 |
| Maxx Luxx LED | Avante | 30 |
| VistOR MS LED | Medical Illumination International, Inc | 21 |
| MI Product Line | Medical Illumination International, Inc | 20 |
| Vision LED | Avante | 18 |
| Fiberoptic Cable | Black & Black Surgical, Inc. | 17 |
| Integra® | Integra Lifesciences (Ireland) Limited | 16 |
| Integra® | Integra LifeSciences Production Corporation | 14 |
| Snowden-Pencer | Steris Corporation | 11 |
| Vistor PRO LED | Medical Illumination International, Inc | 10 |
| Fiber Optic Light Guide | Escalon Medical Corp | 10 |
Showing 12 of 85. All products under Light, Surgical, Fiberoptic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K042034 | 2004-10-26 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.