Electro Surgery System
FDA 510(k) K841165 · Micro-Aire Surgical Instruments, Inc.
510(k) numberK841165
Submission
- Device name
- Electro Surgery System
- Applicant
- Micro-Aire Surgical Instruments, Inc.
Walker, MI, US - Received
- March 19, 1984
- Decision date
- June 5, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GEY – Motor, Surgical Instrument, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Specialty
- General, Plastic Surgery
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| K971782 | Bone and Marrow Collection System KitGEY · Traditional | Biomedical Ent., Inc. | 07/29/1997SE |
| K971268 | Bone & Marrow Cllection SystemGEY · Traditional | Biomedical International Corp. | 07/03/1997SE |
| K964252 | OrthochuckGEY · Traditional | Buckman Co., Inc. | 05/27/1997SE |
| K970530 | Anspach Lubricating System IIGEY · Traditional | The Anspach Effort, Inc. | 05/05/1997SE |
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More from Biomedical Ent., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K904949 | A.O. Synthes,Tap(Replacement)Various Model NumbersHSZ · Traditional | 11/26/1990SE |
| K903713 | Osteotome Model Numbers 2500-228 & 2500-229HSZ · Traditional | 09/14/1990SE |
| K903650 | Oscillating Saw Blades # SO-305,MO-305 and ZO-305HWE · Traditional | 09/14/1990SE |
| K902676 | Microguard, Orthopedic Pin ProtectorsLYT · Traditional | 09/14/1990SE |
| K903664 | Micro-Aire Wire Pass and Craniotome DrillHBE · Traditional | 09/13/1990SE |
| K901967 | Dendia Werk Burs and Cutting DiscsDZP · Traditional | 07/13/1990SE |
| K902168 | Arthroscopic Surgery Blades (Several Models)HRX · Traditional | 06/20/1990SE |
| K901735 | Arthroscopic Surgery Blades DY-3440, 3443, 3444HRX · Traditional | 06/20/1990SE |
| K900033 | Micro-Aire Powered Micro-Surgery InstrumentsGEY · Traditional | 02/13/1990SE |
| K900210 | Bone Harvester System & Osteotome System 2500HSZ · Traditional | 02/02/1990SE |
Questions and answers
When was Electro Surgery System cleared by the FDA?
Electro Surgery System (K841165) received a 510(k) decision of Substantially Equivalent on June 5, 1984, 78 days after the submission was received.
What is the product code of K841165?
The FDA product code is GEY – Motor, Surgical Instrument, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 878.4820.