Data / Medical devices / United States / WCM Waste & Compliance Management, Inc.
WCM Waste & Compliance Management, Inc.: FDA-registered device maker in Carlsbad, CA, United States, 2 510(k) clearances
WCM Waste & Compliance Management, Inc. is registered with the FDA (registration 2032810) in Carlsbad, CA, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 1, 2009. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2032810
- FEI number
- 3004169099
- Address
- 6054 Corte Del Cedro, Carlsbad, CA, United States, 92011
- Owner or operator
- WCM WASTE & COMPLIANCE MANAGEMENT, INC. (9058024)
- Roles
- Manufacturer
- First device listed
- August 13, 2010
- Registered through
- 2026
- Brand names listed
- Isolyser, Isolyser/SMS, Isolyser/SMSm, SMS, Sharps Managment System, Sharps Managment System Mail-Back
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Container, Sharps | MMK | 2 | Manufacturer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 1, 2009 | K090156 | ISOLYSER SHARPS ROOM SYSTEM, MODEL 800; ISOLYSER SHARPS MANAGEMENT SYSTEM, MODELS 2400, 4000, 10000 | FMI | Substantially Equivalent | Wcm Waste & Compliance Management, Inc. | accessdata.fda.gov |
| May 4, 2009 | K090157 | ISOLYSER HOME SHARPS MANAGEMENT (HSM), MODEL 800M; ISOLY SHARPS MANAGEMENT SYSTEM (SMS), MODELS 2400M, 4000M, 10000M, 5. | MMK | Substantially Equivalent | Wcm Waste & Compliance Management, Inc. | accessdata.fda.gov |
Compare with other makers
Updated September 1, 2009. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.