NewGen Surgical

FDA Device Registration & Listing · San Rafael, CA, US · Registration 3010900528

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3010900528
FEI Number
3010900528
Entity Name
NewGen Surgical
City/State/Country
San Rafael, CA, US
Establishment Address
41 Simms St, Suite B, San Rafael, CA 94901, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
NewGen Surgical, Inc. (Owner Number: 10046678)
Owner / Operator Contact Address
41 Simms St, Suite B, San Rafael, CA 94901, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

NewGen Surgical

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GAB Needle, Suturing, Disposable General, Plastic Surgery Class 1 878.4800 2017-11-17

Official Correspondent

Robert Chase

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NewGen Surgical, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010900528. Last updated year: 2026. Please use registration number 3010900528 when referencing this establishment in official correspondence.
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