Data / Medical devices / United States / Aros Surgical Instruments Corporation
Aros Surgical Instruments Corporation: FDA-registered device maker in North Wales, PA, United States, 3 510(k) clearances
Aros Surgical Instruments Corporation is registered with the FDA (registration 2085887) in North Wales, PA, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 18, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2085887
- FEI number
- 1000135614
- Address
- 3627 County Line Road, North Wales, PA, United States, 19454
- Owner or operator
- AROSURGICAL INSTRUMENTS CORP. (9006588)
- Roles
- Specification developer
- First device listed
- November 9, 2007
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Clamp, Vascular | DXC | 2 | Specification developer | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | 2 | 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 |
|---|---|---|---|---|---|---|
| August 18, 2016 | K161315 | Vein Clamps, Artery Clamps | DXC | Substantially Equivalent | Aros Surgical Instruments Corporation | accessdata.fda.gov |
| October 14, 2004 | K042367 | NYLON THREADED NEEDLE | GAR | Substantially Equivalent | Aros Surgical Instruments Corp. | accessdata.fda.gov |
| June 19, 1996 | K961100 | MICRO ANASTOMOSIS CLAMP | DXC | Substantially Equivalent | R.S.P. Medical Management, Inc. | accessdata.fda.gov |
Compare with other makers
Updated August 18, 2016. 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.