Evacuator, Vapor, Cement Monomer
The Cement Monomer Vapor Evacuator is an orthopedic surgical accessory designed to capture and remove toxic vapors generated during the mixing and application of bone cement, protecting operating room personnel from chemical exposure. It is classified as FDA Class 1 (lowest risk), subject only to general controls such as proper labeling and good manufacturing practices. The product code is JDY, regulated under 21 CFR 888.4220, within the Orthopedic medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- JDY
- Device Class
- FDA class 1
- Regulation Number
- 888.4220
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K902167 | CONTAIN(TM) LASER PLUME FILTER | Jan 04, 1991 | Substantially Equivalent | Arbor Technologies, Inc. |
| K902056 | LASER TRAP 100 LASER PLUME SMOKE EVACUATION FILTER | Oct 30, 1990 | Substantially Equivalent | Hollister, Inc. |
| K862509 | CHARCOAL LASER SMOKE FILTER CATALOG NO. 901103-000 | Jul 23, 1986 | Substantially Equivalent | Lifestream Int'L, Inc. |
| K810542 | CEMENT FUME EVACUATOR TANK & FILTER | Mar 13, 1981 | Substantially Equivalent | Walgen Medical Innoventions |
| K790877 | BIOVAC: LFA LASER FUME (SMOKE) EVACUATIO | May 23, 1979 | Substantially Equivalent | Stackhouse Assoc. |
| K780202 | MONOMER EVACUATION SYSTEM | Feb 21, 1978 | Substantially Equivalent | Medishield, Inc. |
| K770690 | MASK, VAPOR, MONOMER | Jul 21, 1977 | Substantially Equivalent | Howmedica Corp. |
| K760906 | MONOMER VAPOR CONTAINMENT SYSTEM | Nov 11, 1976 | Substantially Equivalent | Howmedica Corp. |
FEI Numbers
This FDA classification entry is associated with 23 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 23 registration numbers. Click on an entry to view related FDA registrations.