Data / Medical devices / United States / Monarch Labs, LLC.
Monarch Labs, LLC.: FDA-registered device maker in Irvine, CA, United States, 3 510(k) clearances
Monarch Labs, LLC. is registered with the FDA (registration 3005735989) in Irvine, CA, United States. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated November 2, 2011. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005735989
- Address
- 17875 Sky Park Circle, Suite K, Irvine, CA, United States, 92614
- Owner or operator
- Monarch Labs, LLC (9084766)
- Roles
- Manufacturer, Specification developer
- First device listed
- March 23, 2006
- Registered through
- 2026
- Brand names listed
- Creature Comforts II, LeFlap, MEDICAL MAGGOTS, Medical Maggots, LeSoc Dressings, Medicinal Maggots, Sheer Comfort
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Maggots, Medical | NQK | U | Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| November 2, 2011 | K102827 | MEDICAL MAGGOTS, LESOC | NQK | Substantially Equivalent | Monarch Labs, LLC | accessdata.fda.gov |
| October 5, 2007 | K072438 | MEDICAL MAGGOTS, CREATURE COMFORTS | NQK | Substantially Equivalent | Monarch Labs, LLC | accessdata.fda.gov |
| January 12, 2004 | K033391 | MEDICAL MAGGOTS | NQK | Substantially Equivalent | Ronald A. Sherman | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 3, 2009 | 56031 | Not yet classified | Terminated | Monarch Labs Medical Maggots with the accessory LeFlap dressing (previously known as Creature Comforts II), per vial, Batch #: MM-090406 with CCII-0901. Maggot therapy is intended to debride serious non-healing (chronic) | Monarch Labs initiated the field notification regarding their Medical Maggots from Batch MM090406 with the accessory LeFlap dressing due a customer complaint from a physician of a patient developing cellulitis after using maggots from the affected batch. | accessdata.fda.gov |
Updated November 2, 2011. 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.