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)

Guardenia (GAR-1)

K-Number: K232701 · 2023-09-29

ApplicantAdvanced Surgical Concepts
Decision Date2023-09-29
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Guardenia (GAR-1) is a medical device manufactured by Advanced Surgical Concepts. It received FDA 510(k) clearance on 2023-09-29 under approval number K232701. 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 Guardenia (GAR-1)?

Guardenia (GAR-1) is a medical device that received FDA 510(k) clearance on 2023-09-29. It is manufactured by Advanced Surgical Concepts. The 510(k) number is K232701.

When was Guardenia (GAR-1) approved by the FDA?

Guardenia (GAR-1) received FDA 510(k) clearance on 2023-09-29, under approval number K232701.

What company makes Guardenia (GAR-1)?

Guardenia (GAR-1) is manufactured by Advanced Surgical Concepts.

What is the FDA product code for Guardenia (GAR-1)?

The FDA product code for Guardenia (GAR-1) is GCJ.

Other Devices by Advanced Surgical Concepts

K192898PneumoLiner

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.

↑