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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Trade NameOncoSil™
Generic Namep-32 microparticle for distal cholangiocarcinoma intratumoral injection
Applicant
OncoSil Medical USA, Inc.
215 e woodland rd.
lake bluff, IL 60044
HDE NumberH200002
Date Received08/05/2020
Decision Date08/14/2026
Product Code
SIY
Docket Number FDA-9373
Notice Date 08/18/2026
Advisory Committee Radiology
Supplement Typehde original
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Oncosil™ is intended for intratumoral implantation into a solid tumor via injection under endoscopic ultrasound guidance. Oncosil™ is indicated for the treatment of patients with distal cholangiocarcinoma (dcca) that is both unresectable* and non-metastatic, as an adjunct to systemic therapy. Oncosil™ is indicated for the treatment of patients over 21 years of age. Implantable components of oncosil™ are supplied sterile and are intended for single-patient, single-use. * locally advanced and/or unfit for surgery.
Approval OrderApproval Order
SummarySummary of Safety And Probable Benefit
Labeling
Labeling Part 2
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