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FDA 510(k)

DISPOSABLE SURGICAL TROCAR

K-Number: K943489 · 1994-08-09

ApplicantApplied Medical Resources
Decision Date1994-08-09
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE SURGICAL TROCAR is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources. It received FDA 510(k) clearance on 1994-08-09 under 510(k) number K943489. 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 DISPOSABLE SURGICAL TROCAR?

DISPOSABLE SURGICAL TROCAR is a medical device that received FDA 510(k) clearance on 1994-08-09. The listed applicant is Applied Medical Resources. The 510(k) number is K943489.

When did DISPOSABLE SURGICAL TROCAR receive FDA 510(k) clearance?

DISPOSABLE SURGICAL TROCAR received FDA 510(k) clearance on 1994-08-09, under 510(k) number K943489.

Who is the listed applicant for DISPOSABLE SURGICAL TROCAR?

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

What is the FDA product code for DISPOSABLE SURGICAL TROCAR?

The FDA product code for DISPOSABLE SURGICAL TROCAR is GCJ.

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Other records listing Applied Medical Resources 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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