Data / Medical devices / United States / ORIGAMI SURGICAL Inc.
ORIGAMI SURGICAL Inc.: FDA-registered device maker in Dover, MA, United States, 2 510(k) clearances
ORIGAMI SURGICAL Inc. is registered with the FDA (registration 3010860245) in Dover, MA, United States. It lists 6 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 16, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010860245
- Address
- 79 Haven St., Dover, MA, United States, 02030
- Owner or operator
- Origami Surgical Inc. (10046386)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- March 17, 2014
- Registered through
- 2026
- Brand names listed
- StitchKit, StitchKit HE, StitchKit BA, StitchKit PR, StitchKit RSCP, StitchKit RHP, StitchKit PARK
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene | NBY | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| System, Surgical, Computer Controlled Instrument | NAY | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Tray, Surgical, Needle | FSH | 1 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| July 16, 2021 | K211792 | StitchKit | GAM | Substantially Equivalent | Origami Surgical Inc . | accessdata.fda.gov |
| September 5, 2013 | K123811 | STITCHKIT | NBY | Substantially Equivalent | Origami Surgical, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Tray, Surgical, Needle
- All makers of Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
- All makers of Laparoscope, General & Plastic Surgery
- All makers of System, Surgical, Computer Controlled Instrument
- All makers of Suture, Absorbable, Synthetic, Polyglycolic Acid
- All makers of Suture, Nonabsorbable, Synthetic, Polyethylene
Updated July 16, 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.