Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021192541

FEI Number

3021192541

Entity Name

ORBSURGICAL LTD.

City/State/Country

Calgary Alberta, CA

Establishment Address

HRIC 1C60, 3280 Hospital Drive NW, Calgary Alberta T2N 4Z6, CA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

OrbSurgical Ltd. (Owner Number: 10083634)

Owner / Operator Contact Address

HRIC 1C60, 3280 Hospital Drive NW, Calgary, CA-AB T2N 4Z6, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K051429

PMA Number

N/A

All Registered Proprietary Names

Smartforceps System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-12-07

Official Correspondent

Garnette Sutherland

US Agent Details

Franz Menean Business: MEDAGENT Inc. Email: mail@medagent-usa.com Phone: (603) 5702039

Related Public Records

Same Entity

OrbSurgical Ltd.

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
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

Similar Registrations

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3012940012	Sutter Medical Technologies USA Inc.	Alpharetta, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021192541. Last updated year: 2026. Please use registration number 3021192541 when referencing this establishment in official correspondence.