← FDA Medical Device Classifications

Maggots, Medical

NQK · Unclassified · Unknown

Classification

FDA Product Code
NQK
Device class
Unclassified
Regulation
Review panel
SU
Medical specialty
Unknown
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

Definition

Phaenicia sericacta (blow fly) larvae are harvested and provided disinfected for use in 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. See Federal Register Notice at 89 FR 106521 “Transfer of Regulatory Responsibility From the Center for Devices and Radiological Health to the Center for Biologics Evaluation and Research; Medical Maggots and Medicinal Leeches” (FRN) (FDA-2024-N-5702)

Market data

Cleared 510(k) submissions
6
Registered establishments
1

Source

Authoritative
FDA Device Classification database
Machine
JSON-LD · Markdown