Table, Operating-Room, Pneumatic
A pneumatic operating room table is a patient support platform that uses pneumatic (air pressure) mechanisms to adjust its height and positioning during surgical procedures. It is classified as FDA Class 1 (lowest risk), subject to general controls only, and does not require premarket notification. The product code is FWW, regulated under 21 CFR 878.4960, within the General, Plastic Surgery medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- FWW
- Device Class
- FDA class 1
- Regulation Number
- 878.4960
- 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 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K953961 | OSTEONICS INSIGHT KNEE POSITIONING & ALIGNMENT SYSTEM | Nov 29, 1995 | Substantially Equivalent | Osteonics Corp. |
| K935356 | CAPTAIN'S CHAIR ACCESSORY TO AMSCO SURGICAL TABLES | Mar 23, 1994 | Substantially Equivalent | Amsco American Sterilizer Co. |
| K931876 | FISK ARM SUPPORT | Sep 09, 1993 | Substantially Equivalent | Vvortex International Corp. |
| K924713 | UNIVERSAL SURGICAL INSTRUMENT HOLDER | May 17, 1993 | Substantially Equivalent | T. Korossurgical Instruments Corp. |
| K863161 | TABLE, OPERATING ROOM, HYDRAULIC | Sep 05, 1986 | Substantially Equivalent | Kamiya Tsusan Kaisha, Ltd. |
| K853479 | SKYTRON ELITE 300 SURGERY TABLE | Sep 05, 1985 | Substantially Equivalent | Skytron, Div. the Kmw Group, Inc. |
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.