Is this your brand? Sign in to claim ownership.
Sign in to claim this brandVITALITEC INTERNATIONAL, INC.
US
Last updated May 24, 2026
What VITALITEC INTERNATIONAL, INC. makes
Vitalitec International, Inc. manufactures reusable surgical instruments for open-surgery and endoscopic procedures, including ligation clip appliers, artery clamps, suture knot pushers, and various forceps for tissue manipulation and clamping. Their products are designed for vascular and soft-tissue applications, such as peripheral vascular surgery and endoscopic surgery. Examples include reusable vascular clamps, scissors-like soft-tissue forceps, and clip appliers for securing surgical sites.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The portfolio is regulated under U.S. medical device laws, with individual products authorised through the appropriate FDA clearance or exemption pathways. The manufacturer operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Vitalitec International, Inc. manufacture?
Vitalitec International, Inc. specializes in reusable surgical instruments primarily used in open-surgery and endoscopic procedures. Their product range includes ligation clip appliers for securing tissues, artery clamps for vascular control, suture knot pushers for knot tying, and various forceps—such as clamp manipulation forceps, rigid endoscopic tissue manipulation forceps, and surgical soft-tissue manipulation forceps. These instruments are designed for vascular and soft-tissue applications, including peripheral vascular surgery and endoscopic interventions.
Where is Vitalitec International, Inc. based, and how does that affect its regulatory oversight?
Vitalitec International, Inc. is based in the United States, which means its devices are subject to U.S. medical device regulations. The company’s products are regulated under the FDA’s jurisdiction, with individual devices authorised through pathways like 510(k) clearance or exemptions, depending on their classification. The U.S. regulatory framework ensures compliance with safety, performance, and manufacturing standards specific to the medical device industry.
Which regulatory registries or databases list Vitalitec International, Inc.’s devices?
Vitalitec International, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system is a standardized way to track medical devices throughout their lifecycle, ensuring transparency in regulatory oversight and improving patient safety by enabling better identification and recall management. This listing helps healthcare providers and regulators verify the legitimacy and compliance status of the company’s products.
How are Vitalitec International, Inc.’s devices classified under FDA regulations?
Vitalitec International, Inc.’s devices fall into FDA’s Class I and Class II categories. Class I devices generally pose the lowest risk and may be exempt from premarket notification (510(k)) requirements, while Class II devices require special controls to ensure their safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body area it interacts with—for example, reusable vascular clamps or ligation clip appliers may be classified differently based on their specific surgical applications and associated risks.
Are Vitalitec International, Inc.’s devices reusable, and how does that impact their regulatory requirements?
Yes, many of Vitalitec International, Inc.’s devices are designed for reuse, such as vascular clamps, forceps, and knot pushers. Reusable devices require additional regulatory considerations, including robust cleaning, sterilization, and maintenance protocols to ensure they remain safe and effective for repeated use. The FDA evaluates these instruments under guidelines that address infection control, material durability, and reprocessing validation to maintain their performance and safety throughout their lifecycle.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- [email protected]
- Phone
- 508.747.6033
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 121464288
Catalogue (273)
Page 2 of 6| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Vitalitec Clip Appliers | PBTN220-1B | FDA UDI | Class I | Active |
| MICA Appliers | PWM635-1 | FDA UDI | Class I | Active |
| InTrack® Inserts | N-10171vNS | FDA UDI | Class II | Active |
| Vitalitec Clip Appliers | PL528 | FDA UDI | Class I | Active |
| Vitalitec Knot Pushers | 0530-CSP | FDA UDI | Class I | Active |
| Vitalitec Clip Appliers | PR128 | FDA UDI | Class I | Active |
| Enclose II® | EN235v | FDA UDI | Class II | Active |
| Vitalitec Clip Appliers | PL515-1B | FDA UDI | Class I | Active |
| Novaclips | N-10112NS | FDA UDI | Class II | Active |
| InTrack Clamp | VS00009 | FDA UDI | Class II | Active |
| InTrack Clamp | N-10086v | FDA UDI | Class II | Active |
| Cygnet Clamp | V10152 | FDA UDI | Class II | Active |
| Vitalitec Clip Appliers | PJ115-1 | FDA UDI | Class I | Active |
| Novaclips | N-10113NS | FDA UDI | Class II | Active |
| InTrack® Inserts | N-10176v | FDA UDI | Class II | Active |
| Vitalitec Clip Appliers | PW615 | FDA UDI | Class I | Active |
| Vitalitec Clip Appliers | PWT620 | FDA UDI | Class I | Active |
| Vitalitec Clip Appliers | LCA SLS5/47 | FDA UDI | Class I | Active |
| InTrack® Inserts | N-10175vNS | FDA UDI | Class II | Active |
| Vitalitec Clip Appliers | LCA-12533L | FDA UDI | Class I | Active |
| Vitalitec Clip Appliers | LCASLS-3/20 | FDA UDI | Class I | Active |
| InTrack Clamp | N-10170v | FDA UDI | Class II | Active |
| Vitalitec Clip Appliers | PWT620-1B | FDA UDI | Class I | Active |
| Vitalitec Knot Pushers | 0530-OSP | FDA UDI | Class I | Active |
| InTrack® Inserts | N-10121v | FDA UDI | Class II | Active |
| Vitalitec Shovel Retractors | V9095 | FDA UDI | Class I | Active |
| Cygnet Clamp | VS00052 | FDA UDI | Class II | Active |
| Vitalitec Clip Appliers | VSA-185 | FDA UDI | Class I | Active |
| Cygnet Clamp | VS00055 | FDA UDI | Class II | Active |
| Vitalitec Clip Appliers | GEM615 | FDA UDI | Class I | Active |
| Vitalitec Clip Appliers | POC419-1 | FDA UDI | Class I | Active |
| Vitalitec Clip Appliers | PBC228-1B | FDA UDI | Class I | Active |
| Cygnet Clamp | VS00053 | FDA UDI | Class II | Active |
| InTrack Clamp | N-10077v | FDA UDI | Class II | Active |
| Vitalitec Clip Appliers | PVC328-1B | FDA UDI | Class I | Active |
| InTrack Clamp | N-10075v | FDA UDI | Class II | Active |
| InTrack Clamp | N-10058v | FDA UDI | Class II | Active |
| Vitalitec Clip Appliers | PL515-E | FDA UDI | Class I | Active |
| Vitalitec Clip Appliers | PJ128 | FDA UDI | Class I | Active |
| Vitalitec Clip Appliers | LCA-5mm | FDA UDI | Class I | Active |
| Vitalitec Clip Appliers | PBC228-1 | FDA UDI | Class I | Active |
| InTrack Clamp | N-10132 | FDA UDI | Class II | Active |
| Vitalitec Clip Appliers | PB228-1B | FDA UDI | Class I | Active |
| InTrack® Inserts | N-10121vNS | FDA UDI | Class II | Active |
| Vitalitec Clip Appliers | LCA-0533 M | FDA UDI | Class I | Active |
| InTrack Clamp | N-10330v | FDA UDI | Class II | Active |
| InTrack® Inserts | N-10125vNS | FDA UDI | Class II | Active |
| Vitalitec Clip Appliers | PVC328-E | FDA UDI | Class I | Active |
| InTrack Clamp | N-10072v | FDA UDI | Class II | Active |
| MICA Appliers | PBM235-1 | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.