Data / Medical devices / United States / Envision Endoscopy Inc.
Envision Endoscopy Inc.: FDA-registered device maker in Waltham, MA, United States, 2 510(k) clearances
Envision Endoscopy Inc. is registered with the FDA (registration 3021551844) in Waltham, MA, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 17, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3021551844
- Address
- 204 Second Ave, Waltham, MA, United States, 02451
- Owner or operator
- ENVISION ENDOSCOPY INC. (10095994)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- June 4, 2026
- Registered through
- 2027
- Brand names listed
- SimpleSnip Suture Cutter, SimpleStitch Suturing System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Endoscopic Grasping/Cutting Instrument, Non-Powered | OCZ | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Endoscopic Tissue Approximation Device | OCW | 2 | 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 17, 2025 | K243750 | SimpleStitch Suturing System | OCW | Substantially Equivalent | Envision Endoscopy | accessdata.fda.gov |
| December 20, 2024 | K242923 | SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230) | OCZ | Substantially Equivalent | Envision Endoscopy | accessdata.fda.gov |
Compare with other makers
- All makers of Endoscopic Tissue Approximation Device
- All makers of Endoscopic Grasping/Cutting Instrument, Non-Powered
Updated April 17, 2025. 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.