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FDA 510(k)

TRANSVAGINAL HYDRO LAPAROSCOPY (THL) SYSTEM

K-Number: K992544 · 1999-10-26

ApplicantCircon Corp.
Decision Date1999-10-26
Product CodeHEX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

TRANSVAGINAL HYDRO LAPAROSCOPY (THL) SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Circon Corp.. It received FDA 510(k) clearance on 1999-10-26 under 510(k) number K992544. The device is classified under product code HEX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRANSVAGINAL HYDRO LAPAROSCOPY (THL) SYSTEM?

TRANSVAGINAL HYDRO LAPAROSCOPY (THL) SYSTEM is a medical device that received FDA 510(k) clearance on 1999-10-26. The listed applicant is Circon Corp.. The 510(k) number is K992544.

When did TRANSVAGINAL HYDRO LAPAROSCOPY (THL) SYSTEM receive FDA 510(k) clearance?

TRANSVAGINAL HYDRO LAPAROSCOPY (THL) SYSTEM received FDA 510(k) clearance on 1999-10-26, under 510(k) number K992544.

Who is the listed applicant for TRANSVAGINAL HYDRO LAPAROSCOPY (THL) SYSTEM?

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

What is the FDA product code for TRANSVAGINAL HYDRO LAPAROSCOPY (THL) SYSTEM?

The FDA product code for TRANSVAGINAL HYDRO LAPAROSCOPY (THL) SYSTEM is HEX.

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Other records listing Circon 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.

K992126CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEMK981611SNAP-N-PEEL INTRODUCERSK980972RIGID CULDOSCOPE AND ACCESSORIESK973820USA ELITE SYSTEM VAPORTRODE VAPORIZATION ELECTRODE AND VAPORTOME RESECTION ELECTRODEK964594VAPORTRODE VAPORIZATION ELECTRODE -GROOVED/FLUTED/SPIKED(GVE-B,GVE-F,GVE-S) & VAPORTOMME VAPORIZATION LOOP (GVE-LG)

Related Devices (Code: HEX)

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.

K233043Smart Scope® CXPeriwinkle Technologies Pvt., Ltd.K190187Gynescope SystemIllumigyn , Ltd.K182764Biop Digital ColposcopeBiop Medical , Ltd.K181034Pocket Colposcope SystemHadleigh Health Technologies, LLCK170446LT-300 SD Digital Video ColposcopeLutech Industries, Inc.K161871EVA (Enhanced Visual Assessment) SystemMobileodt , Ltd.

Official Source

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