Home›USA›Cook Endoscopy

Cook Endoscopy

USA · Winston-Salem

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Singapore, Israel — 4 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

11510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 11 510(k), 1 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

39registered devices

Class I 3Class II 36

56 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

1device registrations

CLASS C 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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 States0 registration records, 11 510(k), 1 PMA, 35 excluded

Brazil39 confirmed, 12 excluded

Saudi Arabia0 confirmed, 2 excluded

Canada0 confirmed, 12 excluded

Manufacturer names merged into this page: COOK ENDOSCOPY · WILSON-COOK MEDICAL INC/ COOK ENDOSCOPY · WILSON-COOK MEDICAL INC. / COOK ENDOSCOPY · WILSON-COOK MEDICAL, INC. / COOK ENDOSCOPY

Registration details (sample)

Market	Identifier	Name	Class / date
US	K192697	Instinct Plus Endoscopic Clipping Device	2020-03-05
US	K190829	Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI)	2019-12-19
US	K172665	Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, Models ACU-1 and ACU-1-VL active cords	2018-05-24
BR	10212990040	MANOMETRO DE INSUFLACAO PARA BALAO ENDOSCOPICO	Class II
BR	10212990044	CONJUNTO PARA DRENAGEM NASO-BILIAR	Class II
BR	10212990081	SONDA BIPOLAR PARA COAGULACAO QUICKSILVER	Class II

Cook Endoscopy

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

Similar companies