Data / Medical devices / United States / Sun-Scientific Inc.
Sun-Scientific Inc.: FDA-registered device maker in Dobbs Ferry, NY, United States, 4 510(k) clearances
Sun-Scientific Inc. is registered with the FDA (registration 3008773774) in Dobbs Ferry, NY, United States. It lists 12 device types. The FDA files 4 510(k) clearances under its listings, the newest dated September 7, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008773774
- Address
- 145 Palisade St Suite LL11, Dobbs Ferry, NY, United States, 10522
- Owner or operator
- Sun-Scientific Inc. (10034866)
- Roles
- Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer
- First device listed
- January 11, 2011
- Registered through
- 2026
- Brand names listed
- AW-LLBT Aero-Wrap® Tall, Large, AW-LLBXT Aero-Wrap® Tall, Extra-Large, AW-LMBT Aero-Wrap® Tall, Medium, AW-LSBT Aero-Wrap® Tall, Small, Absorbent pad dressing 5x10, Absorbent pad dressing 5x15, Absorbent pad dressing 5x20, AeroBolster Foam-Large and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Cleaning Brushes, For Endoscope | MNL | 1 | Specification developer | accessdata.fda.gov |
| Accessory, Surgical Apparel | LYU | 1 | Repackager or relabeler | accessdata.fda.gov |
| Bandage, Elastic | FQM | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Dressing, Compression | MHW | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Fiber, Medical, Absorbent | FRL | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Gauze / Sponge,Nonresorbable For External Use | NAB | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Protector, Skin Pressure | FMP | 1 | Specification developer | accessdata.fda.gov |
| Sleeve, Limb, Compressible | JOW | 2 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Splint, Extremity, Inflatable, External | FZF | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Remanufacturer, 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 7, 2023 | K222823 | AeroDVx Arm System | JOW | Substantially Equivalent | Sun Scientific, Inc. | accessdata.fda.gov |
| July 19, 2019 | K183349 | AeroDVx System | JOW | Substantially Equivalent | Sun Scientific, Inc. | accessdata.fda.gov |
| June 29, 2018 | K180389 | Venera 508 Deep Vein Thrombosis (DVT) Prevention System | JOW | Substantially Equivalent | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. | accessdata.fda.gov |
| May 16, 2007 | K070457 | SUN SCIENTIFIC LLC-LEG COMPRESSOR AND PFAB | MHW | Substantially Equivalent | Sun Scientific, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Dressing, Compression
- All makers of Tape And Bandage, Adhesive
- All makers of Sleeve, Limb, Compressible
- All makers of Dressing, Wound, Hydrophilic
- All makers of Protector, Skin Pressure
- All makers of Non-Surgical Gown
Updated September 7, 2023. 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.