Micro-Aire Cutters for Midas-Rex Instruments
FDA 510(k) K894438 · Micro-Aire Surgical Instruments, Inc.
510(k) numberK894438
Submission
- Device name
- Micro-Aire Cutters for Midas-Rex Instruments
- Applicant
- Micro-Aire Surgical Instruments, Inc.
Valencia, CA, US - Received
- July 17, 1989
- Decision date
- August 21, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GFF – Bur, Surgical, General & Plastic Surgery
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GFF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K974025 | Anspach Shielded AttachmentGFF · Traditional | The Anspach Effort, Inc. | 07/06/1998SE |
| K950449 | Surgical BurGFF · Traditional | Transidyne General Corp. | 03/01/1995SE |
| K943758 | Surgical BurGFF · Traditional | Komet Medical | 08/22/1994SE |
| K934583 | BurrsGFF · Traditional | American Medical Specialties, Inc. | 01/26/1994SE |
| K890090 | Danek Irrigating Burr (Dib) SetGFF · Traditional | Danek Medical, Inc. | 01/24/1989SE |
| K883255 | Komet Surgical BurGFF · Traditional | Komet Medical, Div. of Brasseler USA I, L.P. | 09/15/1988SE |
| K880859 | Surgical BursGFF · Traditional | New England Surgical Instrument Corp. | 03/21/1988SE |
| K880706 | Surgical BursGFF · Traditional | Nuell Air Equipment & Hospital Supplies, Inc. | 02/26/1988SE |
| K872475 | Surgical BurGFF · Traditional | Tava Surgical Instruments | 07/02/1987SE |
| K862852 | Micro-Aire Replace Otology Burs/Zim Hall Sur InstrGFF · Traditional | Micro-Aire Surgical Instruments, Inc. | 08/11/1986SE |
More from Micro-Aire Surgical Instruments, 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 Micro-Aire Cutters for Midas-Rex Instruments cleared by the FDA?
Micro-Aire Cutters for Midas-Rex Instruments (K894438) received a 510(k) decision of Substantially Equivalent on August 21, 1989, 35 days after the submission was received.
What is the product code of K894438?
The FDA product code is GFF – Bur, Surgical, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4820.