Data / Medical devices / United States / Vitalitec Int'l., Inc.
Vitalitec Int'l., Inc.: FDA-registered device maker in Plymouth, MA, United States, 5 510(k) clearances
Vitalitec Int'l., Inc. is registered with the FDA (registration 1226015) in Plymouth, MA, United States. It lists 6 device types. The FDA files 5 510(k) clearances under its listings, the newest dated September 5, 2003. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1226015
- FEI number
- 3002539629
- Address
- 10 Cordage Park Cir Suite 100, Plymouth, MA, United States, 02360
- Owner or operator
- VITALITEC INTERNATIONAL INC. (9033784)
- Roles
- Specification developer
- First device listed
- March 10, 2000
- Registered through
- 2026
- Brand names listed
- , CLIPS, CLAMPS, Cygnet Sterilization Tray, Enclose II, INTRACK JAW INSERTS, Microsurgical Reusable Surgical Instrument, Novaclip Spring Clip, Reusable Surgical Instruments and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applier, Surgical, Clip | GDO | 1 | Specification developer | accessdata.fda.gov |
| Clamp, Vascular | DXC | 2 | Specification developer | accessdata.fda.gov |
| Instrument, Clip Removal | HBQ | 1 | Specification developer | accessdata.fda.gov |
| Instrument, Microsurgical | GZX | 1 | Specification developer | accessdata.fda.gov |
| Instruments, Surgical, Cardiovascular | DWS | 1 | Specification developer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | 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 |
|---|---|---|---|---|---|---|
| September 5, 2003 | K032589 | ENCLOSE II ANASTOMOSIS ASSIST DEVICE | DXC | Substantially Equivalent | Novare Surgical Systems, Inc. | accessdata.fda.gov |
| August 9, 2002 | K010727 | FLEXLINE CLAMP | DXC | Substantially Equivalent | Novare Surgical Systems, Inc. | accessdata.fda.gov |
| June 8, 2000 | K992980 | ENGAGE JAW INSERTS | DXC | Substantially Equivalent | Novare Surgical Systems, Inc. | accessdata.fda.gov |
| April 12, 2000 | K000098 | SOFTLINE SPRING CLIP | DXC | Substantially Equivalent | Novare Surgical Systems, Inc. | accessdata.fda.gov |
| September 8, 1999 | K992640 | SLIMLINE SURGICAL CLAMP; SLIMLINE JAW INSERTS | DXC | Substantially Equivalent | Minumys Surgical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Clamp, Vascular
- All makers of Tray, Surgical, Instrument
- All makers of Instrument, Clip Removal
- All makers of Instrument, Microsurgical
- All makers of Instruments, Surgical, Cardiovascular
- All makers of Applier, Surgical, Clip
Updated September 5, 2003. 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.