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Single-Use Flexible Rhinolaryngoscope

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K221581

by Hunan Vathin Medical Instrument Co., Ltd.

Identity

Trade Name
Single-Use Flexible Rhinolaryngoscope FDA UDI
Generic Name
Flexible video otorhinolaryngoscope, single-use FDA UDI
Model / Reference
RL-S1E00 FDA UDI

Identifiers

Primary DI / UDI-DI
06972197480801 FDA UDI
510(k) Number
K221581 FDA 510(k)FDA UDI
FDA Product Code
EOB FDA 510(k)FDA UDI
GMDN Term
Flexible video otorhinolaryngoscope, single-use FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 874.4760 FDA 510(k)
Regulation Number
874.4760 FDA 510(k)FDA UDI
Advisory Committee
Ear, Nose, Throat FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Single-Use Flexible Rhinolaryngoscope by Hunan Vathin Medical Instrument Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Hunan Vathin Medical Instrument Co., Ltd.

Sources (2)

  • FDA 510(k) K221581 24 fields · synced Jun 19, 2026
  • FDA UDI 8e45bc0b-da71-458b-b934-77494b71a95c 33 fields · synced May 27, 2026