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FDA 510(k)

SURGISORB

K-Number: K984374 · 1999-06-04

ApplicantSamyang Corp.
Decision Date1999-06-04
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGISORB is the device name listed in this FDA 510(k) record. The listed applicant is Samyang Corp.. It received FDA 510(k) clearance on 1999-06-04 under 510(k) number K984374. The device is classified under product code GAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGISORB?

SURGISORB is a medical device that received FDA 510(k) clearance on 1999-06-04. The listed applicant is Samyang Corp.. The 510(k) number is K984374.

When did SURGISORB receive FDA 510(k) clearance?

SURGISORB received FDA 510(k) clearance on 1999-06-04, under 510(k) number K984374.

Who is the listed applicant for SURGISORB?

The FDA 510(k) record lists Samyang Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGISORB?

The FDA product code for SURGISORB is GAM.

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.

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Other records listing Samyang Corp. 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.

K990363BIOMESH BIODEGRADABLE GTR BARRIER

Related Devices (Code: GAM)

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.

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Official Source

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