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Pegasus

FDA UDI

Class II (US FDA UDI)

by A.m. Surgical, Inc.

Identity

Trade Name
Pegasus FDA UDI
Generic Name
Rigid optical arthroscope, single-use FDA UDI
Device Name
Pegasus Wireless Endoscopy System - Single Use Arthroscope FDA UDI
Model / Reference
1000 FDA UDI
Description
Pegasus Wireless Endoscopy System - Single Use Arthroscope FDA UDI

Identifiers

Primary DI / UDI-DI
00857915007408 FDA UDI
510(k) Number
K191345 FDA UDI
FDA Product Code
HRX FDA UDI
GMDN Term
Rigid optical arthroscope, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.1100 FDA UDI
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

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Rigid optical arthroscope, single-use

Pegasus by A.m. Surgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Rigid optical arthroscope, single-use.

Cleared under the same submission

K191345 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
A.m. Surgical, Inc.

Sources (1)

  • FDA UDI 4380a7b7-3968-4d4f-8c70-052796cb92e2 35 fields · synced May 29, 2026