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FDA 510(k)

BARIATRIC LAPAROSCOPE, MODEL 367

K-Number: K993045 · 1999-10-27

ApplicantStryker Endoscopy
Decision Date1999-10-27
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BARIATRIC LAPAROSCOPE, MODEL 367 is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Endoscopy. It received FDA 510(k) clearance on 1999-10-27 under 510(k) number K993045. 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 BARIATRIC LAPAROSCOPE, MODEL 367?

BARIATRIC LAPAROSCOPE, MODEL 367 is a medical device that received FDA 510(k) clearance on 1999-10-27. The listed applicant is Stryker Endoscopy. The 510(k) number is K993045.

When did BARIATRIC LAPAROSCOPE, MODEL 367 receive FDA 510(k) clearance?

BARIATRIC LAPAROSCOPE, MODEL 367 received FDA 510(k) clearance on 1999-10-27, under 510(k) number K993045.

Who is the listed applicant for BARIATRIC LAPAROSCOPE, MODEL 367?

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

What is the FDA product code for BARIATRIC LAPAROSCOPE, MODEL 367?

The FDA product code for BARIATRIC LAPAROSCOPE, MODEL 367 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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