Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011050528

FEI Number

3011050528

Entity Name

FREEHOLD SURGICAL, INC.

City/State/Country

New Hope, PA, US

Establishment Address

150 Union Square Dr, New Hope, PA 18938, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Freehold Surgical, LLC (Owner Number: 10047234)

Owner / Operator Contact Address

150 Union Square Dr., New Hope, PA 18938, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

FreeHold Trio Hands-Free Intracorporeal Retractor FreeHold Duo Hands-Free Intracorporeal Retractor

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2014-07-24

Official Correspondent

Elizabeth Bezares

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Freehold Surgical, LLC

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
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19
K820290	The Anspach Effort, Inc.	SELF RETAINING RETRACTOR FOR HAND SURG	1982-03-05
K760422	Cutter Laboratories, Inc.	SURGICAL RETRACTOR	1976-08-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.

Similar Registrations

Registration Number	Establishment Name	Location
3021006167	KIMS MED CO., LTD.	Gwangju, KR
3045009502	WISDOM MEDICAL TECHNOLOGY (SHANGHAI) CO., LTD	Shanghai, CN
3032847175	BIOPHYX SURGICAL, INC.	Edgewater, MD, US
9681129	BEMA-GMBH & CO. KG	EMMINGEN Baden-Wurttemberg, DE
3015972753	STERISERVICE SP. Z O.O.	Czestochowa Slaskie, PL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011050528. Last updated year: 2026. Please use registration number 3011050528 when referencing this establishment in official correspondence.