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Neutral Plate SIEC-NPD/1

by Soniquence, LLC

Neutral Plate SIEC-NPD/1 is a Class II device made by Soniquence, LLC, cleared under FDA 510(k) K183611 on 22 May 2019 and listed in FDA GUDID since 19 May 2020 (UDI-DI 00810026180873), active as of 22 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 22 Oct 2026

Documents

510(k) K183611

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810026180873 UDI-DI Date19 May 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK183611 Date22 May 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K183611 decided 22 May 2019 Active
  • FDA GUDID UDI-DI 00810026180873 listed 19 May 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K183611
  2. Listed FDA GUDID 00810026180873

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Neutral Plate
Generic name
Electrosurgical return electrode, single-use, sterile
Model / Ref / Catalog
SIEC-NPD/1
Primary DI / UDI-DI
00810026180873
510(k) Number
FDA product code
GEI
GMDN term
Electrosurgical return electrode, single-use, sterile
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Electrosurgical return electrode, single-use, sterile

Cleared under the same submission (K183611)

and 8 more cleared under K183611

Similar devices

Other devices filed under FDA product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Other devices from Soniquence, LLC

See all devices from Soniquence, LLC →

Properties

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