Who is the manufacturer of KARL STORZ 10.5 FR. FLEXIBLE HYSTEROSCOPE?

KARL STORZ Endoscopy-America, Inc. filed the 510(k) submission for KARL STORZ 10.5 FR. FLEXIBLE HYSTEROSCOPE (K961605).

What is the FDA product code for KARL STORZ 10.5 FR. FLEXIBLE 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 KARL STORZ 10.5 FR. FLEXIBLE HYSTEROSCOPE?

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

Who can help prepare an FDA 510(k) submission like KARL STORZ 10.5 FR. FLEXIBLE 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.

KARL STORZ 10.5 FR. FLEXIBLE HYSTEROSCOPE

K961605 · KARL STORZ Endoscopy-America, Inc. · HIH · Nov 13, 1996 · Obstetrics/Gynecology

Device Facts

Record ID	K961605
Device Name	KARL STORZ 10.5 FR. FLEXIBLE HYSTEROSCOPE
Applicant	KARL STORZ Endoscopy-America, Inc.
Product Code	HIH · Obstetrics/Gynecology
Decision Date	Nov 13, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 884.1690
Device Class	Class 2

Intended Use

The KSEA flexible hysteroscope is intended for hysteroscopy.

Device Story

Manually operated, reusable flexible fiberscope; 10.5 Fr. diameter; includes working channel. Used by physicians for uterine access and visualization during hysteroscopy procedures in clinical settings. Device provides direct optical visualization of uterine cavity to assist in diagnostic or surgical decision-making. Benefits include minimally invasive access to uterine anatomy.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Flexible fiber optic endoscope; 10.5 Fr. diameter; reusable; manual operation; includes working channel for instrumentation.

Indications for Use

Indicated for hysteroscopy in patients requiring uterine visualization.

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

K013870 — SMITH & NEPHEW OPERATIVE HYSTEROSCOPE, MODEL 7209208; SMITH & NEPHEW CONTINUOUS FLOW SHEATH, MODEL 8105224 · Smith & Nephew, Inc. · Jan 17, 2002
K112134 — TRUCLEAR OPERATIVE HYSTEROSCOPE · Smith & Nephew, Inc. · Nov 22, 2011
K092421 — ALPHAHYSTEROSCOPE, FIBEROPTIC, OPERATIVE AND DIAGNOSTIC · Gimmi GmbH · Feb 12, 2010
K990411 — MVM 7.5 FRENCH FLEXIBLE HYSTEROSCOPE · Karl Storz Endoscopy · May 11, 1999
K192822 — Benesta Hysteroscope · Caldera Medical, Inc. · Sep 9, 2020

Submission Summary (Full Text)

{0} Karl Storz Endoscopy-America, Inc. 600 Corporate Pointe Culver City, California 90230-7600 Phone 310 558 1500 Toll Free 800 421 9437 Fax 310 410 5527 K961605 # 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR. 807.92. All data included in this document are accurate and complete to the best of KSEA’s knowledge. **Applicant:** Karl Storz Endoscopy - America, Inc. 600 Corporate Pointe Culver City, CA 90230 (310) 558-1500 **Contact:** Betty M. Johnson Manager, Regulatory Affairs **Device Identification:** Common Name Hysteroscope, Flexible Fiber Optic Endoscope, Flexible Fiberscope, Flexible Hysterofiberscope Trade Name Karl Storz 10.5 Fr. Flexible Hysteroscope **Indication:** The KSEA flexible hysteroscope is intended for hysteroscopy. **Device Description:** The KSEA 10.5 Fr. flexible hysteroscope is a manually operated, reusable surgical device consisting of a flexible fiberscope with working channel. The instrument is long enough to gain access to the uterus. **Substantial Equivalence:** The KSEA 10.5 Fr. flexible hysteroscope is substantially equivalent to the predicate devices since the basic features, design and intended uses are the same. The minor differences in design and dimensions between the KSEA 10.5 Fr. flexible hysteroscope and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of these devices. Signed: Betty M. Johnson Manager, Regulatory Affairs 000084