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Valleylab E2515

by Covidien LP

Valleylab E2515 is a Class II device made by Covidien LP, cleared under FDA 510(k) K813071 on 10 Nov 1981 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 10884524000497), 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

510(k) K813071

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10884524000497 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK813071 Date10 Nov 1981DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K813071 decided 10 Nov 1981 Active
  • FDA GUDID UDI-DI 10884524000497 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K813071
  2. Listed FDA GUDID 10884524000497

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Valleylab
Generic name
Endoscopic electrosurgical handpiece/electrode, bipolar, single-use
Model / reference
E2515
Primary DI / UDI-DI
10884524000497
510(k) Number
FDA product code
GEI
GMDN term
Endoscopic electrosurgical handpiece/electrode, bipolar, single-use
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution
Size
Length — 10 Feet

Similar devices in this category

Other devices filed under Endoscopic electrosurgical handpiece/electrode, bipolar, single-use.

Other devices from Covidien LP

  • LigaSure MRASILF19

    Class II
  • Shiley 110860

    Class II
  • Shiley 110865

    Class II
  • Shiley 110870

    Class II

See all devices from Covidien LP →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)