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ReNew XR

FDA UDI

Class II (US FDA UDI)

by Microline Surgical, Inc.

Identity

Trade Name
ReNew XR FDA UDI
Generic Name
Endoscopic electrosurgical handpiece/electrode, monopolar, reusable FDA UDI
Model / Reference
3533 FDA UDI

Identifiers

Primary DI / UDI-DI
00811099013853 FDA UDI
510(k) Number
K201884 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Endoscopic electrosurgical handpiece/electrode, monopolar, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4400 FDA UDI
Commercial Distribution
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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Endoscopic electrosurgical handpiece/electrode, monopolar, reusable

ReNew XR by Microline Surgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscopic electrosurgical handpiece/electrode, monopolar, reusable.

Cleared under the same submission

K201884 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Microline Surgical, Inc.

Sources (1)

  • FDA UDI 37b2303c-28a5-402a-b4ac-fd7b86765b67 33 fields · synced May 30, 2026