Data / Medical devices / United States / Activ Surgical Inc
Activ Surgical Inc: FDA-registered device maker in Boston, MA, United States, 3 510(k) clearances
Activ Surgical Inc is registered with the FDA (registration 3021336392) in Boston, MA, United States. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 8, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021336392
- Address
- 27-43 Wormwood St Ste 400, Boston, MA, United States, 02210
- Owner or operator
- ActivSurgical (10083945)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- January 3, 2022
- Registered through
- 2026
- Brand names listed
- Activ Surgical Endoscope Sterilization Tray, Activ Surgical Laparoscope, ActivConnect, ActivSight Intraoperative Imaging System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Confocal Optical Imaging | OWN | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Digital Image Communications, Radiological | LMD | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 8, 2021 | K203550 | ActivSight Intraoperative Imaging System | OWN | Substantially Equivalent | Activ Surgical, Inc. | accessdata.fda.gov |
| August 2, 2002 | K012105 | POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM | KCT | Substantially Equivalent | Symmetry Medical, Inc. | accessdata.fda.gov |
| May 16, 1994 | K941541 | HSV LAPAROSCOPY SET | GCJ | Substantially Equivalent | Henke Sass Wolf of America, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Digital Image Communications, Radiological
- All makers of Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- All makers of Confocal Optical Imaging
- All makers of Laparoscope, General & Plastic Surgery
Updated April 8, 2021. 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.