Surgical Chisel/Osteotome
FDA 510(k) K894785 · Fdt Precision Machine Co., Inc.
510(k) numberK894785
Submission
- Device name
- Surgical Chisel/Osteotome
- Applicant
- Fdt Precision Machine Co., Inc.
Bridgeport, CT, US - Received
- July 27, 1989
- Decision date
- August 18, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KDG – Chisel (Osteotome)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code KDG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K952678 | Sta-Clear Alcohol-Free Endoscopic Anti-Fog KitKDG · Traditional | Avail-Southwest Division | 07/10/1995SE |
| K952200 | Omni-JugKDG · Traditional | Waterstone Medical, Inc. | 06/29/1995SE |
| K891471 | Sil-Med Waste Fluid Dump BagKDG · Traditional | Sil-Med Corp. | 08/15/1989SE |
| K872947 | Porex Quality Plastic Surgery InstrumentsKDG · Traditional | Porex Medical | 08/21/1987SE |
| K872092 | Osteotome Set, Hoke, Straight, Set of 5KDG · Traditional | Military Engineering, Inc. | 06/23/1987SE |
| K842824 | Chermel Bone ChiselsKDG · Traditional | Cher Mel Corp. | 08/02/1984SE |
| K772376 | Neivert OsteotomeKDG · Traditional | Edward Weck, Inc. | 03/09/1978SE |
| K772374 | Silver OsteotomeKDG · Traditional | Edward Weck, Inc. | 03/09/1978SE |
| K772373 | Anderson-Neivert OsteotomeKDG · Traditional | Edward Weck, Inc. | 03/09/1978SE |
| K780135 | Cement Extraction Instrument SetKDG · Traditional | Orthopedic Equipment Co., Inc. | 01/31/1978SE |
Questions and answers
When was Surgical Chisel/Osteotome cleared by the FDA?
Surgical Chisel/Osteotome (K894785) received a 510(k) decision of Substantially Equivalent on August 18, 1989, 22 days after the submission was received.
What is the product code of K894785?
The FDA product code is KDG – Chisel (Osteotome), a Class I (low risk) device regulated under 21 CFR 878.4820.