Single-Use Digital Flexible Ureteroscope (PUR12-1 +8 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K241956

by Hunan Endoso Life Technology Co., Ltd

Identifiers

510(k) Number: K241956 FDA 510(k)
FDA Product Code: FGB FDA 510(k)
Models / Variants: PUR12-1 FDA 510(k)
PUR12-2 FDA 510(k)
PUR12-3 FDA 510(k)
PUR12-4 FDA 510(k)
PUR12-5 FDA 510(k)
PUR12-6 FDA 510(k)
PUR12-S FDA 510(k)
PUR12-S1 FDA 510(k)
PUR12-S2 FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 876.1500 FDA 510(k)
Regulation Number: 876.1500 FDA 510(k)
Advisory Committee: Gastroenterology, Urology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

Single-Use Digital Flexible Ureteroscope (PUR12-1 +8 more) by Hunan Endoso Life Technology Co., Ltd — Class II — FDA_510K — listed in FDA 510(k) — 9 models

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K241956	Class II	Active

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Manufacturer

Manufacturer: Hunan Endoso Life Technology Co., Ltd
FDA Applicant: Hunan Endoso Life Technology Co., Ltd.

Sources (1)

FDA 510(k) K241956 24 fields · synced Jun 18, 2026