PROCELL SURGICAL INC.

FDA Device Registration & Listing · Canton, MA, US · Registration 3016994551

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
3016994551
FEI Number
3016994551
Entity Name
PROCELL SURGICAL INC.
City/State/Country
Canton, MA, US
Establishment Address
780 Dedham St, Suite 700, Canton, MA 02021, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
ProCell Surgical Inc. (Owner Number: 10075210)
Owner / Operator Contact Address
780 Dedham St, Suite 700, Canton, MA 02021, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K193361
PMA Number
N/A

All Registered Proprietary Names

ProCell Surgical Sponge-Blood Recovery Unit

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
CAC Apparatus, Autotransfusion Anesthesiology Class 2 868.5830 2020-06-09

Official Correspondent

Anne Bolin

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K881350 Stryker Corp. CBC/CONSTAVAC BLOOD CONSERVATION SYSTEM 1988-09-30

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016994551. Last updated year: 2026. Please use registration number 3016994551 when referencing this establishment in official correspondence.
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