JDY · Evacuator, Vapor, Cement Monomer
Orthopedic · 21 CFR 888.4220 · Class 1
Overview
| Product Code | JDY |
|---|---|
| Device Name | Evacuator, Vapor, Cement Monomer |
| Regulation | 21 CFR 888.4220 |
| Device Class | Class 1 |
| Review Panel | Orthopedic |
Identification
A cement monomer vapor evacuator is a device intended for use during surgery to contain or remove undesirable fumes, such as monomer vapor from bone cement (§ 888.3027).
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
Cleared Devices (8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K902167 | CONTAIN(TM) LASER PLUME FILTER | Arbor Technologies, Inc. | Jan 4, 1991 | SESE |
| K902056 | LASER TRAP 100 LASER PLUME SMOKE EVACUATION FILTER | Hollister, Inc. | Oct 30, 1990 | SESE |
| K862509 | CHARCOAL LASER SMOKE FILTER CATALOG NO. 901103-000 | Lifestream Int'L, Inc. | Jul 23, 1986 | SESE |
| K810542 | CEMENT FUME EVACUATOR TANK & FILTER | Walgen Medical Innoventions | Mar 13, 1981 | SESE |
| K790877 | BIOVAC: LFA LASER FUME (SMOKE) EVACUATIO | Stackhouse Assoc. | May 23, 1979 | SESE |
| K780202 | MONOMER EVACUATION SYSTEM | Medishield, Inc. | Feb 21, 1978 | SESE |
| K770690 | MASK, VAPOR, MONOMER | Howmedica Corp. | Jul 21, 1977 | SESE |
| K760906 | MONOMER VAPOR CONTAINMENT SYSTEM | Howmedica Corp. | Nov 11, 1976 | SESE |
Top Applicants
- Howmedica Corp. — 2 clearances
- Walgen Medical Innoventions — 1 clearance
- Stackhouse Assoc. — 1 clearance
- Medishield, Inc. — 1 clearance
- Lifestream Int'L, Inc. — 1 clearance
