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FDA 510(k)

LAPAROOPTX(TM) INTRAOPER DEFLECT CHOLEDOCHOSCOPE

K-Number: K912839 · 1991-09-25

ApplicantBaxter Healthcare Corp
Decision Date1991-09-25
Product CodeFBW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LAPAROOPTX(TM) INTRAOPER DEFLECT CHOLEDOCHOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1991-09-25 under 510(k) number K912839. The device is classified under product code FBW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAPAROOPTX(TM) INTRAOPER DEFLECT CHOLEDOCHOSCOPE?

LAPAROOPTX(TM) INTRAOPER DEFLECT CHOLEDOCHOSCOPE is a medical device that received FDA 510(k) clearance on 1991-09-25. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K912839.

When did LAPAROOPTX(TM) INTRAOPER DEFLECT CHOLEDOCHOSCOPE receive FDA 510(k) clearance?

LAPAROOPTX(TM) INTRAOPER DEFLECT CHOLEDOCHOSCOPE received FDA 510(k) clearance on 1991-09-25, under 510(k) number K912839.

Who is the listed applicant for LAPAROOPTX(TM) INTRAOPER DEFLECT CHOLEDOCHOSCOPE?

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

What is the FDA product code for LAPAROOPTX(TM) INTRAOPER DEFLECT CHOLEDOCHOSCOPE?

The FDA product code for LAPAROOPTX(TM) INTRAOPER DEFLECT CHOLEDOCHOSCOPE is FBW.

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Other records listing Baxter Healthcare Corp 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.

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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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