Surgical Bur
FDA 510(k) K943758 · Komet Medical
510(k) numberK943758
Submission
- Device name
- Surgical Bur
- Applicant
- Komet Medical
Savannah, GA, US - Received
- August 2, 1994
- Decision date
- August 22, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| K934583 | BurrsGFF · Traditional | American Medical Specialties, Inc. | 01/26/1994SE |
| K894438 | Micro-Aire Cutters for Midas-Rex InstrumentsGFF · Traditional | Micro-Aire Surgical Instruments, Inc. | 08/21/1989SE |
| 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.
Questions and answers
When was Surgical Bur cleared by the FDA?
Surgical Bur (K943758) received a 510(k) decision of Substantially Equivalent on August 22, 1994, 20 days after the submission was received.
What is the product code of K943758?
The FDA product code is GFF – Bur, Surgical, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4820.