Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Biologics Clearance Letters and 510(k) Summaries Back To Search Results
Device Classification Name maggots, medical
510(k) Number BK251219
Tradenames BioMonde Larval Debridement Therapy Products - BioBag 50/100/200/300/400, BioMonde Larval Debridement Therapy Products - BioBag 50/100/200/300/400 (K142020), BIOMONDE LARVAL DEBRIDEMENT THERAPY PRODUCTS, LARVAE 100/200/300 AND BIOBAG 50/100/200/300/400 (K142020)
Device Name Maggots, Medical
Original Applicant
BioMonde
62 forest street
suite 300
marlborough,  MA  01752
Classification Product Code
NQK  
Date Received05/09/2025
Decision Date 11/05/2014
Decision substantially equivalent (SE)
Review Advisory Committee General & Plastic Surgery
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product No
-
-