Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021336392

FEI Number

3021336392

Entity Name

Activ Surgical Inc

City/State/Country

Boston, MA, US

Establishment Address

27-43 Wormwood St Ste 400, Boston, MA 02210, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

ActivSurgical (Owner Number: 10083945)

Owner / Operator Contact Address

27-43 Wormwood Street, Suite 400, Boston, MA 02210, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K941541

PMA Number

N/A

All Registered Proprietary Names

Activ Surgical Endoscope Sterilization Tray Activ Surgical Laparoscope

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2023-07-20
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2023-06-01

Official Correspondent

Peter Ohanian

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ActivSurgical

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
K243425	Talladium España, SL	Guided DAS Surgical Kit	2025-07-22
K213209	K1 Medical, LLC	EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device	2021-12-28
K012105	Symmetry Medical, Inc.	POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM	2002-08-02
K243317	Infinitum Eta, Ltd.	NUVENTUS NV.C Surgical Cassette and Tray	2025-02-11
K112536	Covidien	SONICISION STERILIZATION TRAY	2012-04-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021336392. Last updated year: 2026. Please use registration number 3021336392 when referencing this establishment in official correspondence.