CleanCoat E3771-45C

CleanCoat E3771-45C is a Class II device made by Covidien LP, cleared under FDA 510(k) K153265 on 5 Jan 2016 and listed in FDA GUDID since 28 Jun 2017 (UDI-DI 10884521550780), active as of 23 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number10884521550780 UDI-DI	Date28 Jun 2017Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK153265	Date5 Jan 2016Decided	StatusActive

Official records

AccessGUDID record UDI-DI 10884521550780
FDA 510(k) database 510(k) number K153265

Across registries

2 registries list this device

FDA 510(k) K153265 decided 5 Jan 2016 Active
FDA GUDID UDI-DI 10884521550780 listed 28 Jun 2017 Listed

Timeline

2 dated events

5 Jan 2016 Cleared FDA 510(k) K153265
28 Jun 2017 Listed FDA GUDID 10884521550780

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: CleanCoat
Generic name: Endoscopic electrosurgical electrode, monopolar, single-use
Model / reference: E3771-45C

Primary DI / UDI-DI: 10884521550780
510(k) Number: K153265
FDA product code: GEI
GMDN term: Endoscopic electrosurgical electrode, monopolar, single-use

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

Size: Length — 45 Centimeter

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Properties

Supplied sterile
Single use
Prescription use
Lot / batch number
Expiration date

Other properties (10, all answered No)