Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System

K-Number: K250411 · 2025-03-12

ApplicantDannik, LLC
Decision Date2025-03-12
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System is a medical device manufactured by Dannik, LLC. It received FDA 510(k) clearance on 2025-03-12 under approval number K250411. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System?

DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System is a medical device that received FDA 510(k) clearance on 2025-03-12. It is manufactured by Dannik, LLC. The 510(k) number is K250411.

When was DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System approved by the FDA?

DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System received FDA 510(k) clearance on 2025-03-12, under approval number K250411.

What company makes DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System?

DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System is manufactured by Dannik, LLC.

What is the FDA product code for DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System?

The FDA product code for DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System is GCJ.

Related Clinical Trials

NCT07475091 Standardizing Swallow Pressure Measurements NOT_YET_RECRUITING NCT07260890 Paired Comparison of SVV and PVI Accuracy COMPLETED NCT01174108 Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells RECRUITING NCT03736226 A Post-Approval, Single-Arm Study of the SYNERGY Stent System in China ACTIVE_NOT_RECRUITING NCT02299102 Comparing Powered Ported Bone Marrow Aspiration to Manual Standard Bone Marrow Aspiration Procedures COMPLETED NCT07608939 Postoperative Pain After Root Canal Treatment Using Different Root Canal Sealers NOT_YET_RECRUITING

Other Devices by Dannik, LLC

K211019Disposable Monopolar Laparoscopic Tips and Reusable Handles K210569Disposable Monopolar Laparoscopic Shafts and Reusable Handles

Related Devices (Code: GCJ)

K163102ReliaCatch Specimen Retrieval Bag 10mm; ReliaCatch Specimen Retrieval Bag 12mmCovidien K160801Well Lead Extraction BagWell Lead Medical Co., Ltd. K153773Disposal Lens Cleaning SheathOlympus Medical Systems Corp. K161720Standard ClampStandard Bariatrics K162445LiVac Retractor SystemLivac Pty, Ltd. K162584VersaOne Bladeless TrocarCovidien

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑