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FDA 510(k)

AUTO SUTURE* SOFT THORACOPORT** OBTURATOR AND SLEEVE

K-Number: K992288 · 1999-07-30

ApplicantTyco Intl. (Us), Inc.
Decision Date1999-07-30
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AUTO SUTURE* SOFT THORACOPORT** OBTURATOR AND SLEEVE is the device name listed in this FDA 510(k) record. The listed applicant is Tyco Intl. (Us), Inc.. It received FDA 510(k) clearance on 1999-07-30 under 510(k) number K992288. 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 AUTO SUTURE* SOFT THORACOPORT** OBTURATOR AND SLEEVE?

AUTO SUTURE* SOFT THORACOPORT** OBTURATOR AND SLEEVE is a medical device that received FDA 510(k) clearance on 1999-07-30. The listed applicant is Tyco Intl. (Us), Inc.. The 510(k) number is K992288.

When did AUTO SUTURE* SOFT THORACOPORT** OBTURATOR AND SLEEVE receive FDA 510(k) clearance?

AUTO SUTURE* SOFT THORACOPORT** OBTURATOR AND SLEEVE received FDA 510(k) clearance on 1999-07-30, under 510(k) number K992288.

Who is the listed applicant for AUTO SUTURE* SOFT THORACOPORT** OBTURATOR AND SLEEVE?

The FDA 510(k) record lists Tyco Intl. (Us), Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTO SUTURE* SOFT THORACOPORT** OBTURATOR AND SLEEVE?

The FDA product code for AUTO SUTURE* SOFT THORACOPORT** OBTURATOR AND SLEEVE is GCJ.

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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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