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FDA 510(k)

EGIS Biliary Double Bare Stent (BDB080405)

K-Number: K242845 · 2025-06-25

Decision Date2025-06-25
Product CodeFGE
Advisory CommitteeGU
DecisionUnknown

Device Summary

EGIS Biliary Double Bare Stent (BDB080405) is the device name listed in this FDA 510(k) record. The listed applicant is S&G Biotech, Inc.. It received FDA 510(k) clearance on 2025-06-25 under 510(k) number K242845. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the EGIS Biliary Double Bare Stent (BDB080405)?

EGIS Biliary Double Bare Stent (BDB080405) is a medical device that received FDA 510(k) clearance on 2025-06-25. The listed applicant is S&G Biotech, Inc.. The 510(k) number is K242845.

When did EGIS Biliary Double Bare Stent (BDB080405) receive FDA 510(k) clearance?

EGIS Biliary Double Bare Stent (BDB080405) received FDA 510(k) clearance on 2025-06-25, under 510(k) number K242845.

Who is the listed applicant for EGIS Biliary Double Bare Stent (BDB080405)?

The FDA 510(k) record lists S&G Biotech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EGIS Biliary Double Bare Stent (BDB080405)?

The FDA product code for EGIS Biliary Double Bare Stent (BDB080405) is FGE.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Other records listing S&G Biotech, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: FGE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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