Abc Handpiece Adapter
FDA 510(k) K901248 · Beacon Laboratories, Inc.
510(k) numberK901248
Submission
- Device name
- Abc Handpiece Adapter
- Applicant
- Beacon Laboratories, Inc.
Broomfield, CO, US - Received
- March 15, 1990
- Decision date
- April 3, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HAM – Apparatus, Electrosurgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code HAM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K153472 | Quiver Laparoscopic ExtendableHAM · Traditional | Itl Corporation Pty, Ltd. | 06/23/2016SE |
| K000079 | Nikopad Electrosurgical Grounding Pad, Model 4777MHAM · Special | Nikomed U.S.A., Inc. | 02/04/2000SE |
| K993306 | Nikopad Electrosurgical Grounding Pad (*Or Sold Under Commercial Names), Model 4760…HAM · Special | Paladin Medical, Inc. | 11/03/1999SE |
| K945861 | Bergen 710 EsuHAM · Traditional | Bergen Mfg. | 03/01/1995SE |
| K913300 | Laparostat(Tm)HAM · Traditional | Cook Ob/Gyn | 04/02/1992SE |
| K920100 | Gsu Handpiece AdapterHAM · Traditional | Beacon Laboratories, Inc. | 02/03/1992SE |
| K911353 | Emc Model No. Statome 900HAM · Traditional | Emc Industries | 06/24/1991SE |
| K881334 | Light Coagulator LC 250HAM · Traditional | Nk-Optik GmbH | 11/16/1989SE |
| K895337 | Electrosurgical Coagulation Suction TubeHAM · Traditional | New England Surgical Instrument Corp. | 09/15/1989SE |
| K894762 | B100 Disposable HandpieceHAM · Traditional | Beacon Laboratories, Inc. | 09/15/1989SE |
More from Beacon Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K930243 | Flexible ExtenderGEI · Traditional | 03/11/1994SE |
| K930497 | Argon HandpiecesGEI · Traditional | 06/25/1993SE |
| K925708 | Disposable Electrosurgery Ball ElectrodeDWG · Traditional | 04/20/1993SE |
| K922289 | Sesquipolar(Tm) Mis ElectrodeGEI · Traditional | 01/15/1993SE |
| K925619 | Disposable Hand-Switching Esu PencilGEI · Traditional | 12/24/1992SE |
| K915788 | Mis Electrosurgical ElectrodesGEI · Traditional | 03/13/1992SE |
| K920100 | Gsu Handpiece AdapterHAM · Traditional | 02/03/1992SE |
| K913772 | Pressure GuardHIF · Traditional | 11/19/1991SE |
| K905752 | Argon Beam Combo Laparoscopic ElectrodeGEI · Traditional | 07/22/1991SE |
| K904506 | Active AdapterGEI · Traditional | 12/13/1990SE |
Questions and answers
When was Abc Handpiece Adapter cleared by the FDA?
Abc Handpiece Adapter (K901248) received a 510(k) decision of Substantially Equivalent on April 3, 1990, 19 days after the submission was received.
What is the product code of K901248?
The FDA product code is HAM – Apparatus, Electrosurgical, a Class II (moderate risk) device regulated under 21 CFR 878.4400.