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FDA 510(k)

THEMO-FLO SYSTEM 3 LAPAROSCOPIC/HYSTEROSCOPIC SYSTEM

K-Number: K941507 · 1995-03-06

ApplicantSanese Medical Corp.
Decision Date1995-03-06
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

THEMO-FLO SYSTEM 3 LAPAROSCOPIC/HYSTEROSCOPIC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sanese Medical Corp.. It received FDA 510(k) clearance on 1995-03-06 under 510(k) number K941507. 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 THEMO-FLO SYSTEM 3 LAPAROSCOPIC/HYSTEROSCOPIC SYSTEM?

THEMO-FLO SYSTEM 3 LAPAROSCOPIC/HYSTEROSCOPIC SYSTEM is a medical device that received FDA 510(k) clearance on 1995-03-06. The listed applicant is Sanese Medical Corp.. The 510(k) number is K941507.

When did THEMO-FLO SYSTEM 3 LAPAROSCOPIC/HYSTEROSCOPIC SYSTEM receive FDA 510(k) clearance?

THEMO-FLO SYSTEM 3 LAPAROSCOPIC/HYSTEROSCOPIC SYSTEM received FDA 510(k) clearance on 1995-03-06, under 510(k) number K941507.

Who is the listed applicant for THEMO-FLO SYSTEM 3 LAPAROSCOPIC/HYSTEROSCOPIC SYSTEM?

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

What is the FDA product code for THEMO-FLO SYSTEM 3 LAPAROSCOPIC/HYSTEROSCOPIC SYSTEM?

The FDA product code for THEMO-FLO SYSTEM 3 LAPAROSCOPIC/HYSTEROSCOPIC SYSTEM is HET.

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Official Source

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