Bard EMS System 6000 E.S.U.
FDA 510(k) K871435 · C.R. Bard, Inc.
510(k) numberK871435
Submission
- Device name
- Bard EMS System 6000 E.S.U.
- Applicant
- C.R. Bard, Inc.
Murray Hill, NJ, US - Received
- April 13, 1987
- Decision date
- May 11, 1987
- 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
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| 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 |
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| K920100 | Gsu Handpiece AdapterHAM · Traditional | Beacon Laboratories, Inc. | 02/03/1992SE |
| K911353 | Emc Model No. Statome 900HAM · Traditional | Emc Industries | 06/24/1991SE |
| K901248 | Abc Handpiece AdapterHAM · Traditional | Beacon Laboratories, Inc. | 04/03/1990SE |
| 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 |
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Questions and answers
When was Bard EMS System 6000 E.S.U. cleared by the FDA?
Bard EMS System 6000 E.S.U. (K871435) received a 510(k) decision of Substantially Equivalent on May 11, 1987, 28 days after the submission was received.
What is the product code of K871435?
The FDA product code is HAM – Apparatus, Electrosurgical, a Class II (moderate risk) device regulated under 21 CFR 878.4400.