Cleared Traditional

K142020 - LARVAL DEBRIDEMENT THERAPY PRODUCTS - LARVAE 100/200/300 AND BIOBAG 50/100/200/300/400 (FDA 510(k) Clearance)

K142020 · Biomonde · General & Plastic Surgery device
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Nov 2014
Decision
103d
Days
-
Risk

K142020 is an FDA 510(k) clearance for the LARVAL DEBRIDEMENT THERAPY PRODUCTS - LARVAE 100/200/300 AND BIOBAG 50/100/20.... Classified as Maggots, Medical (product code NQK).

Submitted by Biomonde (Marlborough, US). The FDA issued a Cleared decision on November 5, 2014 after a review of 103 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 K142020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2014
Decision Date November 05, 2014
Days to Decision 103 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
11d faster than avg
Panel avg: 114d · This submission: 103d
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)