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Sign in to claim this brandPensar Medical, LLC
US
Last updated May 23, 2026
What Pensar Medical, LLC makes
Pensar Medical produces single-use and reusable components for negative-pressure wound therapy (NPWT), including electric systems, canisters, dressing sets, foam dressings (both antimicrobial and non-antimicrobial), tubing sets, connectors, drapes, and carrying cases. These products are designed to manage wound healing through controlled suction therapy, with variations in size and functionality to accommodate different clinical needs.
The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. The portfolio is regulated in the United States, where Pensar Medical is based.
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 Pensar Medical, LLC manufacture?
Pensar Medical, LLC specializes in components and systems for negative-pressure wound therapy (NPWT). Their portfolio includes single-use and reusable items like electric NPWT systems, canisters for fluid collection, dressing sets, foam dressings (both antimicrobial and non-antimicrobial), tubing sets, connectors, drapes, and carrying cases. These devices are designed to promote wound healing by applying controlled suction therapy, with variations tailored to different clinical applications.
Where is Pensar Medical, LLC based, and where are their devices regulated?
Pensar Medical, LLC is based in the United States. Their devices are regulated under U.S. FDA guidelines, specifically as Class II medical devices, which require premarket notification (510(k)) clearance before commercial distribution. This classification applies to their NPWT-related products, ensuring they meet regulatory standards for safety and performance.
Which regulatory databases list Pensar Medical’s devices?
Pensar Medical’s devices are included in the FDA’s 510(k) database, which tracks premarket submissions for Class II medical devices, and the Unique Device Identifier (UDI) database. These registries help track device authorization status, manufacturing details, and compliance with U.S. regulatory requirements for their NPWT systems and components.
How are Pensar Medical’s devices classified under FDA regulations?
Pensar Medical’s devices fall under FDA’s Class II classification, which applies to devices that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness. This classification is common for NPWT systems and accessories, as they involve controlled suction therapy for wound management, necessitating validation of performance and labeling requirements.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 079262228
Catalogue (77)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| MicroDoc NPWT System | 8463550 4007 | FDA UDI | Class II | Active |
| WoundPro UniFlow Connector | 8463540 0674 | FDA UDI | Class II | Active |
| Mini StingRay | 8463540 0810 | FDA UDI | Class II | Active |
| MicroDoc NPWT System | 8463550 5003 | FDA UDI | Class II | Active |
| Basic Series Combo Pack, Medium | 8463540 0584-CB | FDA UDI | Class II | Active |
| Advanced Series Combo Pack, Medium | 8463540 0732-CA | FDA UDI | Class II | Active |
| 300cc Advanced Canister w/5' Tubing | 8463540 0734 | FDA UDI | Class II | Active |
| WoundPro Collection Canister | 8463540 0224 | FDA UDI | Class II | Active |
| WoundPro+ Collection Canister | 8463540 0941 | FDA UDI | Class II | Active |
| WoundPro EZ Clasp Mounting Bracket | 8463540 0278 | FDA UDI | Class II | Active |
| 800cc Basic Canister w/8' Tubing | 8463540 0633 | FDA UDI | Class II | Active |
| MicroDoc NPWT System | 8463550 5001 | FDA UDI | Class II | Active |
| WoundPro Hydrophobic Foam Dressing, Small | 8463540 0577 | FDA UDI | Class II | Active |
| MicroDoc NPWT System | 8463550 4012 | FDA UDI | Class II | Active |
| MicroDoc NPWT System | 8463550 5012 | FDA UDI | Class II | Active |
| MicroDoc NPWT System | 8463550 4017 | FDA UDI | Class II | Active |
| MicroDoc Mini Stingray and Drape Set | 8463550 2003 | FDA UDI | Class II | Active |
| 800cc Advanced Series Canister w/8' Tubing | 8463540 0737 | FDA UDI | Class II | Active |
| MicroDoc NPWT System | 8463550 5002 | FDA UDI | Class II | Active |
| Hydrophilic Foam Dressing, Small | 8463540 0609 | FDA UDI | Class II | Active |
| WoundPro Outer Drape, | 8463540 0802 | FDA UDI | Class II | Active |
| MicroDoc NPWT System | 8463550 5013 | FDA UDI | Class II | Active |
| MicroDoc NPWT System | 8463550 4015 | FDA UDI | Class II | Active |
| Advanced Series Hydrophobic Dressing Kit, Medium | 8463540 0732 | FDA UDI | Class II | Active |
| WoundPro 300cc Basic Canister w/8' Tubing | 8463540 0631 | FDA UDI | Class II | Active |
| PocketDoc™ Micro Wound Therapy System | K200223 | FDA 510(k) | Class II | Active |
| WoundPro Negative Pressure Wound Therapy System | K150960 | FDA 510(k) | Class II | Active |
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