Data / Medical devices / Laparoscope, General & Plastic Surgery, Reprocessed
Laparoscope, General & Plastic Surgery, Reprocessed (NLM): 8 FDA-registered makers in 2 countries
8 establishments in 2 countries are registered with the FDA to make Laparoscope, General & Plastic Surgery, Reprocessed (product code NLM, Class 2, 21 CFR 876.1500). 7 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 23 510(k) clearances under this code, the latest on July 31, 2020, and lists 11 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- NLM
- Device class
- 2
- Regulation
- 876.1500
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| Mexico | 1 |
Makers of Laparoscope, General & Plastic Surgery, Reprocessed
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Stryker Sustainability Solutions Lakeland | Lakeland, FL, United States | Reprocessor | 10 | July 31, 2020 | 0 | 3 | 0 | api.fda.gov |
| Medline ReNewal | Redmond, OR, United States | Reprocessor | 4 | April 15, 2019 | 0 | 1 | 0 | api.fda.gov |
| Stryker Sustainability Solutions | Tempe, AZ, United States | Reprocessor, Specification developer | 3 | July 31, 2020 | 0 | 5 | 0 | api.fda.gov |
| Stryker Sustainability Solutions - Chandler | Chandler, AZ, United States | Reprocessor | 3 | July 31, 2020 | 0 | 0 | 0 | api.fda.gov |
| Renovo, Inc. | Bend, OR, United States | Reprocessor | 2 | October 6, 2017 | 0 | 0 | 0 | api.fda.gov |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 1 | April 15, 2019 | 0 | 0 | 0 | api.fda.gov |
| Stryker Tijuana Operations | Tijuana Baja California, Mexico | Reprocessor | 1 | October 11, 2006 | 0 | 0 | 0 | api.fda.gov |
| Nypro Inc (Maple Grove) | Maple Grove, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 31, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.