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Apollo Endosurgery, Inc.

USA · Austin

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel — 9 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

14510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 14 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

7registered devices

Class II 7

10 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

4active device licences

Class II 2Class III 2

TWTaiwanTFDA

3valid device licences

Class II 1Class III 2

SGSingaporeHSA SMDR

2device registrations

CLASS C 2

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

7active ARTG entries

IIa 2IIb 5

HKHong KongMDACS

1valid listings

Class III 1

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, 14 510(k), 0 PMA, 1 excluded

Brazil7 confirmed, 0 excluded

Canada4 confirmed, 0 excluded

Manufacturer names merged into this page: APOLLO ENDOSURGERY, INC. · APOLLO ENDOSURGERY, INC

Registration details (sample)

Market	Identifier	Name	Class / date
US	K232544	Apollo ESG NXT System, Apollo REVISE NXT System	2023-09-18
US	K231553	OverStitch NXT Endoscopic Suturing System	2023-06-29
US	DEN210045	APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System	2022-07-12
BR	10341359016	Sistema de sutura endoscópica OverStitch NXT	Class II
BR	10341359010	Sistema de sutura endoscópica OverStitch Sx	Class II
BR	10341359011	Dispositivo HELIX	Class II
CA	62480	BIOENTERICS GASTRIC BALLOON SUCTION CATHETER	Class II
CA	69203	LAP-BAND ACCESS PORT KIT	Class III
CA	72168	ORBERA SYSTEM INTRAGASTRIC BALLOON	Class III

Apollo Endosurgery, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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