ReNew XR 3533

by Microline Surgical, Inc.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

in data synced 22 Oct 2026

Documents

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00811099013853 UDI-DI	Date7 Jun 2023Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k) from GUDID	NumberK201884	Date21 Oct 2020Issued	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: ReNew XR
Generic name: Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Model / reference: 3533

Primary DI / UDI-DI: 00811099013853
510(k) Number: K201884
FDA product code: GEI
GMDN term: Endoscopic electrosurgical handpiece/electrode, monopolar, reusable

Device class: Class II
Regulation number: 878.4400
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

Other devices from Microline Surgical, Inc.

ReNew 3412

Class II
ReNew 3362

Class II
ReNew 3946

Class II
ReNew 3411

Class II
Microline 132-135D

Class II
ReNew 3322

Class II

See all devices from Microline Surgical, Inc. →

Properties

Sterilise before use
Prescription use
Serial number
Manufacturing date

Other properties (11)

Supplied sterile: No
Single use: No
Implantable: No
Contains latex: No
Over-the-counter: No
Convenience kit: No
Combination product: No
HCT/P: No
Premarket exempt: No
Lot / batch number: No
Expiration date: No