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FDA 510(k)

STERILE DISPOSABLE TROCAR-SLEEVE DEVICES

K-Number: K862611 · 1986-07-23

ApplicantUnited States Surgical, A Division of Tyco Healthc
Decision Date1986-07-23
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

STERILE DISPOSABLE TROCAR-SLEEVE DEVICES is the device name listed in this FDA 510(k) record. The listed applicant is United States Surgical, A Division of Tyco Healthc. It received FDA 510(k) clearance on 1986-07-23 under 510(k) number K862611. 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 STERILE DISPOSABLE TROCAR-SLEEVE DEVICES?

STERILE DISPOSABLE TROCAR-SLEEVE DEVICES is a medical device that received FDA 510(k) clearance on 1986-07-23. The listed applicant is United States Surgical, A Division of Tyco Healthc. The 510(k) number is K862611.

When did STERILE DISPOSABLE TROCAR-SLEEVE DEVICES receive FDA 510(k) clearance?

STERILE DISPOSABLE TROCAR-SLEEVE DEVICES received FDA 510(k) clearance on 1986-07-23, under 510(k) number K862611.

Who is the listed applicant for STERILE DISPOSABLE TROCAR-SLEEVE DEVICES?

The FDA 510(k) record lists United States Surgical, A Division of Tyco Healthc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERILE DISPOSABLE TROCAR-SLEEVE DEVICES?

The FDA product code for STERILE DISPOSABLE TROCAR-SLEEVE DEVICES is GCJ.

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Other records listing United States Surgical, A Division of Tyco Healthc as applicant

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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

View on FDA Database →

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

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