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FDA 510(k)

INTUITIVE SURGICAL SEAL

K-Number: K060534 · 2006-03-13

ApplicantApplied Medical Resources Corp.
Decision Date2006-03-13
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INTUITIVE SURGICAL SEAL is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources Corp.. It received FDA 510(k) clearance on 2006-03-13 under 510(k) number K060534. 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 INTUITIVE SURGICAL SEAL?

INTUITIVE SURGICAL SEAL is a medical device that received FDA 510(k) clearance on 2006-03-13. The listed applicant is Applied Medical Resources Corp.. The 510(k) number is K060534.

When did INTUITIVE SURGICAL SEAL receive FDA 510(k) clearance?

INTUITIVE SURGICAL SEAL received FDA 510(k) clearance on 2006-03-13, under 510(k) number K060534.

Who is the listed applicant for INTUITIVE SURGICAL SEAL?

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

What is the FDA product code for INTUITIVE SURGICAL SEAL?

The FDA product code for INTUITIVE SURGICAL SEAL is GCJ.

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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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