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Monarch Endoscopy Platform (P1) Tower Upgrade

FDA UDI

Class II (US FDA UDI)

by Auris Health, Inc.

Identity

Trade Name
Monarch Endoscopy Platform (P1) Tower Upgrade FDA UDI
Generic Name
Robotic surgical arm system FDA UDI
Device Name
Monarch Endoscopy Platform (P1) Tower Upgrade FDA UDI
Model / Reference
MON-000005-01 FDA UDI
Description
Monarch Endoscopy Platform (P1) Tower Upgrade FDA UDI

Identifiers

Primary DI / UDI-DI
B634MON00000501 FDA UDI
510(k) Number
K173760 FDA UDI
FDA Product Code
EOQ FDA UDI
JAK FDA UDI
GMDN Term
Robotic surgical arm system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.4680 FDA UDI
892.1750 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Monarch Endoscopy Platform (P1) Tower Upgrade by Auris Health, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K173760 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Auris Health, Inc.

Sources (1)

  • FDA UDI 105c1c53-dec4-4acc-845f-2cffa6618fa1 35 fields · synced Jun 8, 2026