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Valleylab SEP6015NSB

by Covidien LP

Valleylab SEP6015NSB is a Class II device made by Covidien LP, cleared under FDA 510(k) K182772 on 19 Nov 2018 and listed in FDA GUDID since 23 Oct 2021 (UDI-DI 10884521751125), 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) K182772

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 Number10884521751125 UDI-DI Date23 Oct 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK182772 Date19 Nov 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K182772 decided 19 Nov 2018 Active
  • FDA GUDID UDI-DI 10884521751125 listed 23 Oct 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K182772
  2. Listed FDA GUDID 10884521751125

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  • Withdrawn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
Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
Model / reference
SEP6015NSB
Primary DI / UDI-DI
10884521751125
510(k) Number
FDA product code
GEI
GMDN term
Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution
Size
Length — 4.6 Meter

Related devices

Category: Open-surgery electrosurgical handpiece/electrode, monopolar, single-use

Cleared under the same submission (K182772)

Similar devices in this category

Other devices filed under Open-surgery electrosurgical handpiece/electrode, monopolar, 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

  • Single use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)