Saw, Pneumatically Powered
Pneumatically Powered Saw is a surgical instrument driven by compressed air, used to cut bone during orthopedic, plastic, or general surgical procedures, offering controlled cutting force and reduced heat generation compared to manual saws. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, meaning it does not require premarket notification or approval. The product code is KFK, regulated under 21 CFR 878.4820, within the General, Plastic Surgery medical specialty.
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Basic Information
- Product Code
- KFK
- Device Class
- FDA class 1
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K893949 | #157 EXAM LIGHT | Aug 07, 1989 | Substantially Equivalent | Medmark, Inc. |
| K894301 | MICRO-AIRE STERNUM SAW 4800 | Aug 03, 1989 | Substantially Equivalent | Micro Surgical Instruments Corp. |
| K870157 | OSCILLATING SAW/ RECIPROCATING SAW/ DRILL-REAMER | Feb 24, 1987 | Substantially Equivalent | Micro-Aire Surgical Instruments, Inc. |
| K801737 | STERNUM SAW | Aug 20, 1980 | Substantially Equivalent | Amsco Co. |
FEI Numbers
This FDA classification entry is associated with 15 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 15 registration numbers. Click on an entry to view related FDA registrations.