KDGClass I

Chisel (Osteotome)

21 CFR 878.4820 / General, Plastic Surgery

KDG is the FDA product code for Chisel (Osteotome), a class I device type, regulated under 21 CFR 878.4820. As of 2026-09-10, FDA records hold 11 510(k) clearances under this code, the most recent dated 1995-07-10, and 14 recalls.

Classification record

Product code: KDG
Device name: Chisel (Osteotome)
Regulation: 21 CFR 878.4820
Device class: Class I
Review panel: General, Plastic Surgery
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 11
Ingested recalls: 14

Clearances, product code KDG

By decision year

11 clearances under product code KDG with a decision year between 1978 and 1995, 1978 the highest year at 4.

Show the numbers

510(k) clearances under FDA product code KDG by decision year
Year	Clearances
1978	4
1984	1
1987	2
1989	2
1995	2

Applicants with the most clearances

Product code KDG

Applicants holding the most 510(k) clearances under product code KDG
Applicant	Clearances
Edward Weck, Inc.	3
Avail-Southwest Division	1
Cher Mel Corp.	1
Fdt Precision Machine Co., Inc.	1
Military Engineering, Inc.	1
Orthopedic Equipment Co., Inc.	1
Porex Medical	1
Sil-Med Corp.	1
Waterstone Medical, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 85 companies shown, in name order