Apparatus, Air Handling, Enclosure
The Apparatus, Air Handling, Enclosure (product code FZI) is an enclosure-type air handling device used in surgical settings to create a controlled airflow environment around a specific workstation or patient zone, reducing contamination risk. It is classified as FDA Class 2, which is moderate risk and requires a 510(k) premarket submission to demonstrate substantial equivalence. The device is regulated under 21 CFR 878.5070 within the General, Plastic Surgery specialty (SU). No special flags apply to this device.
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Basic Information
- Product Code
- FZI
- Device Class
- FDA class 2
- Regulation Number
- 878.5070
- 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 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K911132 | MULTIPLE, SURGICAL DRAPE PACK | May 06, 1991 | Substantially Equivalent | Central Georgia Ancillary Health Systems |
| K910468 | STERILE DISPOSABLE DRAPE(S) | Mar 21, 1991 | Substantially Equivalent | E.M. Adams |
| K854159 | ELLIPTI-PUNCH | Nov 15, 1985 | Substantially Equivalent | Alcon Laboratories |
| K772395 | DAVIS RHYTIDECTOMY | Mar 09, 1978 | Substantially Equivalent | Edward Weck, Inc. |
| K772394 | KALRN FACE-LIFE SCISSORS | Mar 09, 1978 | Substantially Equivalent | Edward Weck, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.