Acuvu Medical System Inc,

FDA Device Registration & Listing · Los Altos, CA, US · Registration 3023365313

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
3023365313
FEI Number
3023365313
Entity Name
Acuvu Medical System Inc,
City/State/Country
Los Altos, CA, US
Establishment Address
4546 El Camino Real Suite 234, Los Altos, CA 94022, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Process Control Services (Owner Number: 10083910)
Owner / Operator Contact Address
5 Oak Forest Court, Portola Valley, CA 94028, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K254050
PMA Number
N/A

All Registered Proprietary Names

Manual Tissue Removal Device Manual Tissue Removal

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2026-05-22

Official Correspondent

Sam Mostafavi

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Process Control Services
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3021610866 Suzhou Acuvu Medical Technology Co., Ltd. Suzhou Jiangsu, CN

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K935716 KARL STORZ Endoscopy-America, Inc. KARL STORZ FIXED MAGNIFICATION TELESCOPE/KS VARIABLE MAGNIFICATION TELESCOPE 1995-11-16

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9611612 PAJUNK GMBH MEDIZINTECHNOLOGIE GEISINGEN Baden-Wurttemberg, DE
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023365313. Last updated year: 2026. Please use registration number 3023365313 when referencing this establishment in official correspondence.
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