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510(k) Data Aggregation
K Number
K102827Device Name
MEDICAL MAGGOTS, LESOC
Manufacturer
Date Cleared
2011-11-02
(399 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
MONARCH LABS, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Medical Maggots are indicated for debriding non-healing necrotic skin and soft tissue wounds, including pressure ulcers, venous stasis ulcers, neuropathic foot ulcers, and non-healing traumatic or post surgical wounds.
The accessory maggot confinement dressings, Creature Comforts™, and LeFlap™ and LeSoc™, are indicated for confining the medicinal maggots on the area of treatment during debridement therapy for the conditions mentioned above.
Device Description
Phaenicia sericata larvae (see Figure 1)
Common names: Maggot dressings; green blow fly maggots; disinfected maggots; sterile maggots; therapeutic maggots; debriding maggots; maggot debridement therapy. Accessories: MDT dressings; maggot confinement dressings; maggot cage dressings.
"Proprietary" name: Medical Maggots; to be used with Creature Comforts or LeSoc (the latter being the new accessory featured in this Special PMN)
Maggot therapy is essentially a controlled wound myiasis (maggot infessation). The maggots macerate their food with their mouth hooks, release their digestive enzymes into the local environment, and ingest the liquefying and semi-solid tissue. As they grow, they molt twice. When satiated, the maggots leave their food source, burry themselves in a suitably protected area, and pupate. Adult flies emerge (eclose) approximately 1-3 weeks later. Maggot therapy dressings contain the medical grade larvae on the wound during the period of debridement, and facilitate easy and controlled removal when the patient and therapist determine they have completed their work.
The proposed modified accessory ("LeSoc") has the same basic structure and use as the previously approved "Sterile Nylon Stocking," with the exception that we will make the stocking out of a different polyester fabric: the same polyester monofilament fabric that we currently use in the production of our approved Creature Comforts dressing (our flat, non-stocking dressing). This means that the stocking weave will be fixed, not free to move or stretch.
The structure, function, technology and indications are the same as in the currently marketed products. The only difference will be the offering of a hybrid dressing accessory to create a stocking-like dressing out of our currently used fixed-weave polyester net instead of the stretch-weave polyester of our Sterile Nylon Stockings.
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K Number
K072438Device Name
MEDICAL MAGGOTS, CREATURE COMFORTS
Manufacturer
Date Cleared
2007-10-05
(36 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
MONARCH LABS, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Medical Maggots are indicated for debriding non-healing necrotic skin and soft tissue wounds, including pressure ulcers, venous stasis ulcers, neuropathic foot ulcers, and nonhealing traumatic or post surgical -wounds.
The accessory maggot confinement dressings, Creature Comforts and Creature Comforts II, are indicated for confining the medicinal maggots on the area of treatment during debridement therapy for the conditions mentioned above.
Device Description
Phaenicia sericata larvae (Medical Maggots) and maggot confinement dressings (Creature Comforts and Creature Comforts II). The maggots are used for debridement of non-healing necrotic skin and soft tissue wounds. The dressings are used to confine the maggots on the wound. The modified accessory is a pre-assembled version of the hydrocolloid-netting cage.
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