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FDA 510(k)

FLEXIBLE FIBER OPTIC LAPAROSCOPES

K-Number: K943598 · 1994-10-18

ApplicantOptimed Technologies, Inc.
Decision Date1994-10-18
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FLEXIBLE FIBER OPTIC LAPAROSCOPES is the device name listed in this FDA 510(k) record. The listed applicant is Optimed Technologies, Inc.. It received FDA 510(k) clearance on 1994-10-18 under 510(k) number K943598. 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 FLEXIBLE FIBER OPTIC LAPAROSCOPES?

FLEXIBLE FIBER OPTIC LAPAROSCOPES is a medical device that received FDA 510(k) clearance on 1994-10-18. The listed applicant is Optimed Technologies, Inc.. The 510(k) number is K943598.

When did FLEXIBLE FIBER OPTIC LAPAROSCOPES receive FDA 510(k) clearance?

FLEXIBLE FIBER OPTIC LAPAROSCOPES received FDA 510(k) clearance on 1994-10-18, under 510(k) number K943598.

Who is the listed applicant for FLEXIBLE FIBER OPTIC LAPAROSCOPES?

The FDA 510(k) record lists Optimed Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLEXIBLE FIBER OPTIC LAPAROSCOPES?

The FDA product code for FLEXIBLE FIBER OPTIC LAPAROSCOPES is HET.

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Other records listing Optimed Technologies, Inc. as applicant

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K972520OPTIVIEWK955275BOOSTER TROPHY 5 MOTORIZED SCOOTERK955276BOOSTER LITE 4 MOTORIZED SCOOTERK955274BOOSTER LITE 3 MOTORIZED SCOOTERK926597LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)K921942HYSTEROSCOPE (AND ACCESSORIES)

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Related Devices (Code: HET)

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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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