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FDA 510(k)

ENDOCOLLECT Specimen Retrieval Bag

K-Number: K232519 · 2024-01-05

ApplicantXimedica
Decision Date2024-01-05
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOCOLLECT Specimen Retrieval Bag is a medical device manufactured by Ximedica. It received FDA 510(k) clearance on 2024-01-05 under approval number K232519. 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 ENDOCOLLECT Specimen Retrieval Bag?

ENDOCOLLECT Specimen Retrieval Bag is a medical device that received FDA 510(k) clearance on 2024-01-05. It is manufactured by Ximedica. The 510(k) number is K232519.

When was ENDOCOLLECT Specimen Retrieval Bag approved by the FDA?

ENDOCOLLECT Specimen Retrieval Bag received FDA 510(k) clearance on 2024-01-05, under approval number K232519.

What company makes ENDOCOLLECT Specimen Retrieval Bag?

ENDOCOLLECT Specimen Retrieval Bag is manufactured by Ximedica.

What is the FDA product code for ENDOCOLLECT Specimen Retrieval Bag?

The FDA product code for ENDOCOLLECT Specimen Retrieval Bag is GCJ.

Other Devices by Ximedica

Related Devices (Code: GCJ)

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.