Skip to content

Bovie A902

by Aspen Surgical Products, Inc. 2 variants

Bovie A902 is a Class II device made by Aspen Surgical Products, Inc., cleared under FDA 510(k) K000961 on 19 Apr 2000 and listed in FDA GUDID since 26 Aug 2024 (UDI-DI 00887482032732), 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) K000961

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 Number00887482032732 UDI-DI Date26 Aug 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK000961 Date19 Apr 2000DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K000961 decided 19 Apr 2000 Active
  • FDA GUDID UDI-DI 00887482032732 listed 26 Aug 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K000961
  2. Listed FDA GUDID 00887482032732

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  • Withdrawn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 handpiece/electrode, monopolar, single-use
Model / reference
A902
Primary DI / UDI-DI
00887482032732
510(k) Number
FDA product code
GEI
GMDN term
Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Open-surgery electrosurgical handpiece/electrode, monopolar, single-use

Cleared under the same submission (K000961)

and 2 more cleared under K000961

Similar devices in this category

Other devices filed under Open-surgery electrosurgical handpiece/electrode, monopolar, single-use.

Other devices from Aspen Surgical Products, Inc.

See all devices from Aspen Surgical Products, Inc. →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (10, all answered No)