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Bovie AA00

by Aspen Surgical Products, Inc. 4 variants

Bovie AA00 is a Class II device made by Aspen Surgical Products, Inc., cleared under FDA 510(k) K945493 on 30 Jan 1995 and listed in FDA GUDID since 28 Aug 2024 (UDI-DI 10887482175160), 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) K945493

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 Number10887482175160 UDI-DI Date28 Aug 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK945493 Date30 Jan 1995DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K945493 decided 30 Jan 1995 Active
  • FDA GUDID UDI-DI 10887482175160 listed 28 Aug 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K945493
  2. Listed FDA GUDID 10887482175160

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  • Withdrawn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
Electrocautery system generator, battery-powered
Model / reference
AA00
Primary DI / UDI-DI
10887482175160
510(k) Number
FDA product code
HQP
GMDN term
Electrocautery system generator, battery-powered
Device class
Class II
Regulation number
886.4115
GUDID distribution status
In Commercial Distribution

Related devices

Category: Electrocautery system generator, battery-powered

Cleared under the same submission (K945493)

Similar devices in this category

Other devices filed under Electrocautery system generator, battery-powered.

Other devices from Aspen Surgical Products, Inc.

See all devices from Aspen Surgical Products, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)