Who else makes this device?

Name: Generator
Brand: Generator

Generator · Coagulator, Laparoscopic, Unipolar (And Accessories) → Obstetrics & Gynecology

1manufacturer

1catalogue number

3510(k) clearances naming this product code

Who Else Makes It

Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code HFG
Manufacturer	City	Province	Registered as	Device types
ATL Technology DG,Ltd.	Dongguan	Guangdong	Contract manufacturer	14

Record

Regulatory record for Generator
Listed by	Halt Medical, Inc., United States
FDA product code	HFG
Device type	Coagulator, Laparoscopic, Unipolar (And Accessories)
Device class	Class 2
Regulation	21 CFR 884.4160
Record published	2016-09-19
Record revised	2023-09-18 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Generator
Catalogue number	Size	Status
1000		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Conmed	ConMed Corporation	12
Acessa ProVu System	Hologic, Inc.	8
Guidance controller	Halt Medical, Inc.	1
Guidance field generator	Halt Medical, Inc.	1
Acessa ProVu Dual Foot Pedal	Acessa Health, Inc.	1
Guidance handpiece	Halt Medical, Inc.	1
Handpiece cable	Halt Medical, Inc.	1
Guidance handpiece cable	Halt Medical, Inc.	1
Guidance ultrasound transducer sleeve	Halt Medical, Inc.	1
Pads	Halt Medical, Inc.	1
Pad cable	Halt Medical, Inc.	1
Handpiece	Halt Medical, Inc.	1

Showing 12 of 14. All products under Coagulator, Laparoscopic, Unipolar (And Accessories)

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K132744	2014-05-27
K132184	2014-04-28
K121858	2012-11-05

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Generator