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FDA 510(k)

TROCAR/CANNULA/SHEATH SET

K-Number: K853337 · 1985-08-23

ApplicantAmerican Edwards Laboratories
Decision Date1985-08-23
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TROCAR/CANNULA/SHEATH SET is the device name listed in this FDA 510(k) record. The listed applicant is American Edwards Laboratories. It received FDA 510(k) clearance on 1985-08-23 under 510(k) number K853337. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TROCAR/CANNULA/SHEATH SET?

TROCAR/CANNULA/SHEATH SET is a medical device that received FDA 510(k) clearance on 1985-08-23. The listed applicant is American Edwards Laboratories. The 510(k) number is K853337.

When did TROCAR/CANNULA/SHEATH SET receive FDA 510(k) clearance?

TROCAR/CANNULA/SHEATH SET received FDA 510(k) clearance on 1985-08-23, under 510(k) number K853337.

Who is the listed applicant for TROCAR/CANNULA/SHEATH SET?

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

What is the FDA product code for TROCAR/CANNULA/SHEATH SET?

The FDA product code for TROCAR/CANNULA/SHEATH SET is KOD.

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Related Devices (Code: KOD)

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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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