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DeRoyal 88-000101

by Deroyal Industries, Inc.

DeRoyal 88-000101 is a Class II device made by Deroyal Industries, Inc., cleared under FDA 510(k) K130027 on 22 Aug 2013 and listed in FDA GUDID since 12 Sep 2016 (UDI-DI 00749756126410), 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) K130027

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 Number00749756126410 UDI-DI Date12 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK130027 Date22 Aug 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K130027 decided 22 Aug 2013 Active
  • FDA GUDID UDI-DI 00749756126410 listed 12 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K130027
  2. Listed FDA GUDID 00749756126410

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
DeRoyal
Generic name
Electrosurgical return electrode, single-use, sterile
Model / reference
88-000101
Primary DI / UDI-DI
00749756126410
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

Related devices

Category: Electrosurgical return electrode, single-use, sterile

Cleared under the same submission (K130027)

and 8 more cleared under K130027

Similar devices

Other devices filed under FDA product code GEI (ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES).

Other devices from Deroyal Industries, Inc.

See all devices from Deroyal Industries, Inc. →

Properties

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