Who is the manufacturer of HYSTEROSCOPE?

Conceptus, Inc. filed the 510(k) submission for HYSTEROSCOPE (K954164).

What is the FDA product code for HYSTEROSCOPE?

HIH. It is classified under 21 CFR 884.1690 as a Class 2 device in the Obstetrics/Gynecology panel.

What is the regulatory pathway for HYSTEROSCOPE?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like HYSTEROSCOPE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

HYSTEROSCOPE

K954164 · Conceptus, Inc. · HIH · Mar 12, 1996 · Obstetrics/Gynecology

Device Facts

Record ID	K954164
Device Name	HYSTEROSCOPE
Applicant	Conceptus, Inc.
Product Code	HIH · Obstetrics/Gynecology
Decision Date	Mar 12, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 884.1690
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Conceptus hysteroscope is used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix for both diagnostic and operative procedures.

Device Story

Rigid hysteroscope with flexible articulating tip; telescopic optical system; conveys images to user eye or video camera; used by physicians in clinical settings for diagnostic and operative uterine procedures; enables direct visualization of cervical canal and uterine cavity.

Technological Characteristics

Rigid shaft with flexible articulating tip; telescopic optical system; includes eyepiece plug and light guide plug; manual operation.

Indications for Use

Indicated for patients requiring direct visualization of the cervical canal and uterine cavity for diagnostic or operative gynecological procedures.

Regulatory Classification

Identification

A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.

Related Devices

K112134 — TRUCLEAR OPERATIVE HYSTEROSCOPE · Smith & Nephew, Inc. · Nov 22, 2011
K972426 — MICROSPAN GOLD HYSTEROSCOPE AND MICROSPAN HYSTEROSCOPE SHEATH · Imagyn Medical, Inc. · Sep 23, 1997
K990411 — MVM 7.5 FRENCH FLEXIBLE HYSTEROSCOPE · Karl Storz Endoscopy · May 11, 1999
K141515 — AED HYSTEROSCOPE AND ACCESSORIES · National Advanced Endoscopy Devices, Inc. · Jan 7, 2015
K961605 — KARL STORZ 10.5 FR. FLEXIBLE HYSTEROSCOPE · KARL STORZ Endoscopy-America, Inc. · Nov 13, 1996

Submission Summary (Full Text)

{0} MAR 12 1996 # Conceptus K954164 ## Conceptus Hysteroscope ## Summary of Safety and Effectiveness This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990. The Conceptus hysteroscope is used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix for both diagnostic and operative procedures. The Conceptus hysteroscope has a rigid shaft with a flexible articulating tip. The device is equipped with a separate eyepiece plug and light guide plug. The optical system conveys an image to the user’s eye or to a video camera. The intended use, optics, design, materials, specifications and mode of operation of the Conceptus Hysteroscope were found to be substantially equivalent to several predicate hysteroscopes. K954164 Conceptus, Inc. • 1021 Howard Avenue, San Carlos, CA 94070 Phone:415/802-7240 Fax:415/802-7272 220