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Bovie ES47

by Aspen Surgical Products, Inc. 3 variants

Bovie ES47 is a Class II device made by Aspen Surgical Products, Inc., cleared under FDA 510(k) K931338 on 16 Feb 1994 and listed in FDA GUDID since 27 Aug 2024 (UDI-DI 10887482178703), 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) K931338

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 Number10887482178703 UDI-DI Date27 Aug 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK931338 Date16 Feb 1994DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K931338 decided 16 Feb 1994 Active
  • FDA GUDID UDI-DI 10887482178703 listed 27 Aug 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K931338
  2. Listed FDA GUDID 10887482178703

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  • Withdrawn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
Open-surgery electrosurgical electrode, monopolar, single-use
Model / reference
ES47
Primary DI / UDI-DI
10887482178703
FDA product code
HGI
GMDN term
Open-surgery electrosurgical electrode, monopolar, single-use
Device class
Class II
Regulation number
884.4120
GUDID distribution status
In Commercial Distribution
Size
Width — 25 Millimeter
Length — 10 Millimeter

Related devices

Category: Open-surgery electrosurgical electrode, monopolar, reusable

Cleared under the same submission (K931338)

and 8 more cleared under K931338

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)