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FDA 510(k)

RIGID FIBER OPTIC LAPAROSCOPE

K-Number: K962246 · 1997-02-07

ApplicantHealth Care International Assoc.
Decision Date1997-02-07
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

RIGID FIBER OPTIC LAPAROSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Health Care International Assoc.. It received FDA 510(k) clearance on 1997-02-07 under 510(k) number K962246. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RIGID FIBER OPTIC LAPAROSCOPE?

RIGID FIBER OPTIC LAPAROSCOPE is a medical device that received FDA 510(k) clearance on 1997-02-07. The listed applicant is Health Care International Assoc.. The 510(k) number is K962246.

When did RIGID FIBER OPTIC LAPAROSCOPE receive FDA 510(k) clearance?

RIGID FIBER OPTIC LAPAROSCOPE received FDA 510(k) clearance on 1997-02-07, under 510(k) number K962246.

Who is the listed applicant for RIGID FIBER OPTIC LAPAROSCOPE?

The FDA 510(k) record lists Health Care International Assoc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RIGID FIBER OPTIC LAPAROSCOPE?

The FDA product code for RIGID FIBER OPTIC LAPAROSCOPE is HET.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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