KDG — Chisel (Osteotome) Class I
FDA product code KDG covers "Chisel (Osteotome)", a Class I medical device regulated under 21 CFR 878.4820. Submissions are reviewed by the General, Plastic Surgery panel. At least 11 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KDG
- Device Class
- Class I
- Regulation Number
- 878.4820
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K952678 | avail-southwest division | STA-CLEAR ALCOHOL-FREE ENDOSCOPIC ANTI-FOG KIT | July 10, 1995 |
| K952200 | waterstone medical | OMNI-JUG | June 29, 1995 |
| K894785 | fdt precision machine co | SURGICAL CHISEL/OSTEOTOME | August 18, 1989 |
| K891471 | sil-med | SIL-MED WASTE FLUID DUMP BAG | August 15, 1989 |
| K872947 | porex medical | POREX QUALITY PLASTIC SURGERY INSTRUMENTS | August 21, 1987 |
| K872092 | military engineering | OSTEOTOME SET, HOKE, STRAIGHT, SET OF 5 | June 23, 1987 |
| K842824 | cher mel | CHERMEL BONE CHISELS | August 2, 1984 |
| K772374 | edward weck | SILVER OSTEOTOME | March 9, 1978 |
| K772373 | edward weck | ANDERSON-NEIVERT OSTEOTOME | March 9, 1978 |
| K772376 | edward weck | NEIVERT OSTEOTOME | March 9, 1978 |
| K780135 | orthopedic equipment co | CEMENT EXTRACTION INSTRUMENT SET | January 31, 1978 |