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510(k) Data Aggregation
K Number
K250411Device Name
DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System
Manufacturer
Dannik, LLC
Date Cleared
2025-03-12
(27 days)
Product Code
GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Dannik, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval Devices are indicated for use as a receptacle for the collection and extraction of tissue, organs, and calculi during general and laparoscopic surgery.
Device Description
The DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System are sterile single patient use devices, which comprise of a flexible plastic bag with a deployment mechanism. The bag is supplied pre-loaded in the introducer assembly and consists of a large, easily accessible opening and a closure suture that facilitates closure of the specimen bag after the specimen(s) have been collected. The deployment mechanism consists of a push-pull rod and an introducer assembly. The deployment mechanism allows for easy insertion through the cannula and full deployment of the bag with the use of the biasing arms.
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