Cleared Traditional

K131221 - LARVAL DEBRIDEMENT THERAPY PRODUCTS - BIOBAG 50/100/200/300/400 (FDA 510(k) Clearance)

K131221 · Biomonde · General & Plastic Surgery device
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Aug 2013
Decision
120d
Days
-
Risk

K131221 is an FDA 510(k) clearance for the LARVAL DEBRIDEMENT THERAPY PRODUCTS - BIOBAG 50/100/200/300/400. Classified as Maggots, Medical (product code NQK).

Submitted by Biomonde (Marlborough, US). The FDA issued a Cleared decision on August 28, 2013 after a review of 120 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K131221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2013
Decision Date August 28, 2013
Days to Decision 120 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 114d · This submission: 120d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NQK Maggots, Medical
Device Class -
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)