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HK SURGICAL, INC.

USA · San Clemente

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Australia — 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

12listed device types

Class I 9Class II 3Class III 0

plus 13 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class I 1Class II 1

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

0active device licences

2 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

12active ARTG entries

Class I 7IIa 3Class Is (sterile) 2

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 States13 registration records, 4 510(k), 0 PMA, 23 excluded

Brazil2 confirmed, 7 excluded

Saudi Arabia0 confirmed, 5 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: HK SURGICAL, INC. · HK SURGICAL, INC

FDA 510(k) clearances by year

22003 · K032802

12013 · K123822

12020 · K193664

FDA listed device types

showing 8 of 12

Syringe, Irrigating (Non Dental) 1Stand, Infusion 1Cannula, Surgical, General & Plastic Surgery 1Tray, Biopsy, Without Biopsy Instruments 1Gown, Examination 1Binder, Elastic 1Fiber, Medical, Absorbent 1Accessories, Catheter 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K193664	SubQKath Catheter and Needle Set	2020-09-09
US	K123822	KLEIN TOUCH PUMP AND DISPOSABLE TUBING SET	2013-09-27
US	K032802	HK LIPOSUCTION ASPIRATOR, MODEL AP-III & AP230-III	2003-11-19
BR	81831840001	FLUIDFREE®	Class I
BR	81831840005	FLUIDFREE® NÃO ESTÉRIL	Class II

HK SURGICAL, 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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