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Bovie H103

by Aspen Surgical Products, Inc. 4 variants

Bovie H103 is a Class II device made by Aspen Surgical Products, Inc., cleared under FDA 510(k) K945758 on 21 Apr 1995 and listed in FDA GUDID since 28 Aug 2024 (UDI-DI 10887482179588), 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) K945758

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 Number10887482179588 UDI-DI Date28 Aug 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK945758 Date21 Apr 1995DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K945758 decided 21 Apr 1995 Active
  • FDA GUDID UDI-DI 10887482179588 listed 28 Aug 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K945758
  2. Listed FDA GUDID 10887482179588

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  • Withdrawn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
H103
Primary DI / UDI-DI
10887482179588
510(k) Number
FDA product code
GEI
GMDN term
Electrocautery system generator, battery-powered
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution

Related devices

Category: Electrocautery system generator, battery-powered

Cleared under the same submission (K945758)

and 8 more cleared under K945758

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)