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FDA 510(k)

CHRISTOUDIAS PERITONEUM TWIN TISSUE APPROXIMATOR

K-Number: K942597 · 1994-08-15

ApplicantHolmed Corp.
Decision Date1994-08-15
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CHRISTOUDIAS PERITONEUM TWIN TISSUE APPROXIMATOR is the device name listed in this FDA 510(k) record. The listed applicant is Holmed Corp.. It received FDA 510(k) clearance on 1994-08-15 under 510(k) number K942597. 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 CHRISTOUDIAS PERITONEUM TWIN TISSUE APPROXIMATOR?

CHRISTOUDIAS PERITONEUM TWIN TISSUE APPROXIMATOR is a medical device that received FDA 510(k) clearance on 1994-08-15. The listed applicant is Holmed Corp.. The 510(k) number is K942597.

When did CHRISTOUDIAS PERITONEUM TWIN TISSUE APPROXIMATOR receive FDA 510(k) clearance?

CHRISTOUDIAS PERITONEUM TWIN TISSUE APPROXIMATOR received FDA 510(k) clearance on 1994-08-15, under 510(k) number K942597.

Who is the listed applicant for CHRISTOUDIAS PERITONEUM TWIN TISSUE APPROXIMATOR?

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

What is the FDA product code for CHRISTOUDIAS PERITONEUM TWIN TISSUE APPROXIMATOR?

The FDA product code for CHRISTOUDIAS PERITONEUM TWIN TISSUE APPROXIMATOR is GCJ.

Related Clinical Trials

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Other records listing Holmed 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.

K930330ENDOSCOPIC NEEDLEHOLDER, MODIFICATION

Related Devices (Code: GCJ)

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

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