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Bovie A802EU

by Aspen Surgical Products, Inc. 2 variants

Bovie A802EU is a Class II device made by Aspen Surgical Products, Inc., cleared under FDA 510(k) K092761 on 24 Nov 2009 and listed in FDA GUDID since 26 Aug 2024 (UDI-DI 00887482177020), 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) K092761

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 Number00887482177020 UDI-DI Date26 Aug 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK092761 Date24 Nov 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K092761 decided 24 Nov 2009 Active
  • FDA GUDID UDI-DI 00887482177020 listed 26 Aug 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K092761
  2. Listed FDA GUDID 00887482177020

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Bovie
Generic name
Electrosurgical return electrode, reusable
Model / reference
A802EU
Primary DI / UDI-DI
00887482177020
510(k) Number
FDA product code
GEI
GMDN term
Electrosurgical return electrode, reusable
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution

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Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)