Data / Medical devices / United States / Nanofiber Solutions LLC
Nanofiber Solutions LLC: FDA-registered device maker in Dublin, OH, United States, 6 510(k) clearances
Nanofiber Solutions LLC is registered with the FDA (registration 3014527904) in Dublin, OH, United States. It lists 3 device types. The FDA files 6 510(k) clearances under its listings, the newest dated February 27, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014527904
- Address
- 5164 Blazer Parkway, Dublin, OH, United States, 43017
- Owner or operator
- Nanofiber Solutions LLC (10057315)
- Roles
- Manufacturer
- First device listed
- March 20, 2018
- Registered through
- 2026
- Brand names listed
- BIOCHARGE, Phoenix Wound Matrix, Rotium
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Absorbable Synthetic Wound Dressing | QSZ | U | Manufacturer | accessdata.fda.gov |
| Fastener, Fixation, Biodegradable, Soft Tissue | MAI | 2 | Manufacturer | accessdata.fda.gov |
| Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon | OWW | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| February 27, 2025 | K250021 | Rotium | OWW | Substantially Equivalent | Nanofiber Solutions, LLC | accessdata.fda.gov |
| July 29, 2024 | K241912 | BIOCHARGE | MAI | Substantially Equivalent | Nanofiber Solutions, LLC | accessdata.fda.gov |
| July 5, 2023 | K231641 | Rotium Bioresorbable Wick | MAI | Substantially Equivalent | Nanofiber Solutions, LLC | accessdata.fda.gov |
| June 25, 2020 | K201414 | Rotium Bioresorbable Wick | MAI | Substantially Equivalent | Nanofiber Solutions, LLC | accessdata.fda.gov |
| March 11, 2019 | K183236 | Rotium Bioresorbable Wick | MAI | Substantially Equivalent | Nanofiber Solutions, LLC | accessdata.fda.gov |
| March 2, 2018 | K173544 | Phoenix Wound Matrix | QSZ | Substantially Equivalent | Nanofiber Solutions, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
- All makers of Fastener, Fixation, Biodegradable, Soft Tissue
- All makers of Absorbable Synthetic Wound Dressing
Updated February 27, 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.