Surgical Burs
FDA 510(k) K880859 · New England Surgical Instrument Corp.
510(k) numberK880859
Submission
- Device name
- Surgical Burs
- Applicant
- New England Surgical Instrument Corp.
Rockland, MA, US - Received
- March 1, 1988
- Decision date
- March 21, 1988
- 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 |
| 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 |
| 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 |
|---|---|---|
| K895337 | Electrosurgical Coagulation Suction TubeHAM · Traditional | 09/15/1989SE |
| K895331 | Electrosurgical ElectrodeJOS · Traditional | 09/15/1989SE |
| K883963 | Raney and Leroy-Raney Scalp ClipHBO · Traditional | 10/07/1988SE |
| K883396 | Handswitching Monopolar PencilGEI · Traditional | 09/13/1988SE |
| K880863 | Bipolar Micro Coagulator Models 25-1000 & 25-1200GEI · Traditional | 04/19/1988SE |
| K872271 | Various Sizes & Styles of Monopolar ForcepsGEN · Traditional | 06/26/1987SE |
| K872209 | Arthroplasty MalletHXL · Traditional | 06/23/1987SE |
| K864770 | Suction TubeFFA · Traditional | 02/24/1987SE |
| K864775 | Chisel (Osteotome, Gouge, Etc.)EMM · Traditional | 02/12/1987SE |
| K864771 | Chuck HandleGEI · Traditional | 02/04/1987SE |
Questions and answers
When was Surgical Burs cleared by the FDA?
Surgical Burs (K880859) received a 510(k) decision of Substantially Equivalent on March 21, 1988, 20 days after the submission was received.
What is the product code of K880859?
The FDA product code is GFF – Bur, Surgical, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4820.