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Origami Surgical Inc .

USA · Dover

✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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

6listed device types

Class I 1Class II 5Class III 0

plus 3 registration records and 7 510(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

0active device licences

TWTaiwanTFDA

pendingnot queried

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 States3 registration records, 7 510(k), 0 PMA

Manufacturer names merged into this page: ORIGAMI SURGICAL Inc.

FDA 510(k) clearances by year

12013 · K123811

12014 · K142639

12018 · K173874

12019 · K191317

22021 · K211792

12023 · K221527

FDA listed device types

Tray, Surgical, Needle 1System, Surgical, Computer Controlled Instrument 1Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene 1Suture, Nonabsorbable, Synthetic, Polyethylene 1Suture, Absorbable, Synthetic, Polyglycolic Acid 1Laparoscope, General & Plastic Surgery 1

Market	Identifier	Name	Class / date
US	K221527	StitchKit	2023-02-14
US	K211792	StitchKit	2021-07-16
US	K202950	StitchKit COMBO	2021-02-23

Origami 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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