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Prosurg, Inc.

USA · San Jose

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

4listed device types

Class I 0Class II 4Class III 0

plus 4 registration records and 16 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

1active device licences

Class II 1

6 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States4 registration records, 16 510(k), 0 PMA

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: Prosurg, Inc · PROSURG, INC.

FDA 510(k) clearances by year

22000

12002

22003

22005

12006

42007

12012

32016

FDA listed device types

Electrosurgical, Cutting & Coagulation & Accessories 1Arthroscope 1Cystoscope And Accessories, Flexible/Rigid 1Laparoscope, General & Plastic Surgery 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K152511	Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannula	2016-07-11
US	K152466	Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible)	2016-05-19
US	K152619	Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible)	2016-04-29
CA	24581	PROSTAJECT INJECTOR	Class II

Prosurg, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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