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FDA 510(k)

HENKE SASS WOLF OF AMERICA BARIATRIC LAPAROSCOPE

K-Number: K050163 · 2005-03-24

ApplicantHenke Sass Wolf of America, Inc.
Decision Date2005-03-24
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HENKE SASS WOLF OF AMERICA BARIATRIC LAPAROSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Henke Sass Wolf of America, Inc.. It received FDA 510(k) clearance on 2005-03-24 under 510(k) number K050163. 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 HENKE SASS WOLF OF AMERICA BARIATRIC LAPAROSCOPE?

HENKE SASS WOLF OF AMERICA BARIATRIC LAPAROSCOPE is a medical device that received FDA 510(k) clearance on 2005-03-24. The listed applicant is Henke Sass Wolf of America, Inc.. The 510(k) number is K050163.

When did HENKE SASS WOLF OF AMERICA BARIATRIC LAPAROSCOPE receive FDA 510(k) clearance?

HENKE SASS WOLF OF AMERICA BARIATRIC LAPAROSCOPE received FDA 510(k) clearance on 2005-03-24, under 510(k) number K050163.

Who is the listed applicant for HENKE SASS WOLF OF AMERICA BARIATRIC LAPAROSCOPE?

The FDA 510(k) record lists Henke Sass Wolf of America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HENKE SASS WOLF OF AMERICA BARIATRIC LAPAROSCOPE?

The FDA product code for HENKE SASS WOLF OF AMERICA BARIATRIC LAPAROSCOPE is GCJ.

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Other records listing Henke Sass Wolf of America, Inc. as applicant

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.

K080560HENKE SASS WOLF OF AMERICA ARTHROSCOPEK030572HENKE SASS WOLF OF AMERICA NASOPHARYNGOSCOPEK013611HENKE SASS WOLF SAPHENOUS VEIN LAPAROSCOPEK991563CONTINUOUS FLOW HYSTERO-RESECTOSCOPE, KNIFE ELECTRODE, SPIKE ELECTRODE, VAPORISATION ELECTRODE, COAGULATION ELECTRODE, CK983067FINE-JECTK981751SINUSCOPE AND ACCESSORIES

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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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