FDA product code KDG: Chisel (Osteotome)
KDG is the FDA product code for chisel (osteotome). It is a Class I device, regulated under 21 CFR 878.4820 and reviewed by the General and Plastic Surgery panel. FDA has cleared 11 510(k) submissions under KDG, from 9 different applicants. The average 510(k) review took 49 days (median 28). FDA has posted 14 recalls for KDG devices.
Classification
| Field | Value |
|---|---|
| Device name | Chisel (Osteotome) |
| Device class | Class I |
| Regulation | 21 CFR 878.4820 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KDG clearance
Top KDG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Edward Weck, Inc. | 3 | 1978-03-09 |
| Avail-Southwest Division | 1 | 1995-07-10 |
| Waterstone Medical, Inc. | 1 | 1995-06-29 |
| Fdt Precision Machine Co., Inc. | 1 | 1989-08-18 |
| Sil-Med Corp. | 1 | 1989-08-15 |
4 more applicants have KDG clearances. See the full list in Caduvo.
Most recent KDG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K952678 | Avail-Southwest Division | STA-CLEAR ALCOHOL-FREE ENDOSCOPIC ANTI-FOG KIT | 1995-07-10 | 28 |
| K952200 | Waterstone Medical, Inc. | OMNI-JUG | 1995-06-29 | 50 |
| K894785 | Fdt Precision Machine Co., Inc. | SURGICAL CHISEL/OSTEOTOME | 1989-08-18 | 22 |
| K891471 | Sil-Med Corp. | SIL-MED WASTE FLUID DUMP BAG | 1989-08-15 | 153 |
| K872947 | Porex Medical | POREX QUALITY PLASTIC SURGERY INSTRUMENTS | 1987-08-21 | 24 |
Recalls for KDG devices
14 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-01-11.
| Year | Recalls |
|---|---|
| 2017 | 12 |
| 2018 | 1 |
| 2019 | 1 |
Frequently asked questions
What is FDA product code KDG?
KDG is the FDA product code for chisel (osteotome). It is a Class I device, regulated under 21 CFR 878.4820 and reviewed by the General and Plastic Surgery panel.
What device class is KDG?
Class I, regulation 21 CFR 878.4820. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KDG?
Across 11 cleared submissions the average was 49 days from receipt to decision (median 28).
Which companies have the most KDG clearances?
Edward Weck, Inc. (3); Avail-Southwest Division (1); Waterstone Medical, Inc. (1); Fdt Precision Machine Co., Inc. (1); Sil-Med Corp. (1).
Have KDG devices been recalled?
Yes: 14 product recalls across 3 recall events; the most recent began 2019-01-11.
Next steps
- Run an FDA pathway report with predicate devices for product code KDG
- Run a recall and safety report across every KDG manufacturer
- Watch product code KDG for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All General and Plastic Surgery product codes · FDA product code lookup · 510(k) database search · 510(k) review times