Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2085887

FEI Number

1000135614

Entity Name

AROS SURGICAL INSTRUMENTS CORPORATION

City/State/Country

North Wales, PA, US

Establishment Address

3627 County Line Road, North Wales, PA 19454, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

AROSURGICAL INSTRUMENTS CORP. (Owner Number: 9006588)

Owner / Operator Contact Address

3627 Country Line Road, --, North Wales, PA 19454, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K161315

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAR	Suture, Nonabsorbable, Synthetic, Polyamide	General, Plastic Surgery	Class 2	878.5020	2007-11-09
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2007-11-09
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2019-03-26

Official Correspondent

Robyn Scopis

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

AROSURGICAL INSTRUMENTS CORP.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0034-2009	Surgical Specialties Corp	2	3-0 Black Mono Nylon Suture, 12 units per box. product number 925B. The product intended for use in general soft tissue approximation and/or ligation including use in ophthalmic procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2085887. Last updated year: 2026. Please use registration number 2085887 when referencing this establishment in official correspondence.