Who is the manufacturer of FEMRX MORCELLATOR SYSTEM?

Gynecare Innovation Center filed the 510(k) submission for FEMRX MORCELLATOR SYSTEM (K963872).

What is the FDA product code for FEMRX MORCELLATOR SYSTEM?

HET. It is classified under 21 CFR 884.1720 as a Class 2 device in the Obstetrics/Gynecology panel.

What is the regulatory pathway for FEMRX MORCELLATOR SYSTEM?

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

Who can help prepare an FDA 510(k) submission like FEMRX MORCELLATOR SYSTEM?

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.

FEMRX MORCELLATOR SYSTEM

Q: What are the predicate devices for FEMRX MORCELLATOR SYSTEM?

Karl Storz STEINER™ Morcellator.

K963872 · Gynecare Innovation Center · HET · Jan 17, 1997 · Obstetrics/Gynecology

Device Facts

Record ID	K963872
Device Name	FEMRX MORCELLATOR SYSTEM
Applicant	Gynecare Innovation Center
Product Code	HET · Obstetrics/Gynecology
Decision Date	Jan 17, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 884.1720
Device Class	Class 2
Attributes	Therapeutic

Device Story

FemRx™ Morcellator System; motor-driven rotating cutting blade within cylindrical housing; tissue extraction via central lumen using forceps; disposable device; utilizes previously cleared FemRx™ Motor Drive Unit (MDU) (K954648, K962506); fixed non-rotating inner cylinder reduces torsional/rotational force on tissue fragments during extraction; used in endoscopic surgical settings; physician-operated; facilitates removal of tissue samples.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and mechanical comparison to predicate.

Technological Characteristics

Motor-driven rotating cutting blade; cylindrical housing; fixed inner non-rotating cylinder; disposable; medical grade non-toxic materials; external motor drive unit (MDU) connection via flexible drive cable.

Indications for Use

Indicated for cutting or coring tissue during endoscopic procedures, specifically for tissue extraction.

Regulatory Classification

Identification

A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.

Predicate Devices

Karl Storz STEINER™ Morcellator

Reference Devices

FemRx™ OPERA STAR™ Hysteroscopic System (K954648)
FemRx™ TURP STAR™ Urological Resectoscopic System (K962506)

Related Devices

K061050 — GYNECARE MORCELLEX TISSUE MORCELLATOR, MODELS MX0100 AND MX0100R · ETHICON, Inc. · Jul 14, 2006
K041774 — IUR RECIPROCATING MORCELLATOR MODEL # 7210517 · Smith & Nephew, Inc. · Oct 7, 2004
K982515 — POWER-DRIVE, WISAP MODEL #7688PD/7688PD1 · Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh · Jan 19, 1999
K993801 — GYNECARE LAPAROSCOPIC MORCELLATOR · ETHICON, Inc. · Feb 7, 2000
K061180 — KSEA ROTOCUT G1 ELECTROMECHANICAL MORCELLATOR · KARL STORZ Endoscopy-America, Inc. · Jul 27, 2006

Submission Summary (Full Text)

{0} JAN 17 1997 510(k) SUMMARY K963872 The FemRx™ Morcellator System is virtually identical to the currently marketed Karl Storz STEINER™ Morcellator in terms of its tissue cutting and extraction mechanism. Both devices utilize a separate motor drive box and flexible drive cable to drive a rotating cutting blade, internal to a cylindrical housing, used to cut or core tissue as it is drawn up through the central lumen of the device by the use of standard forceps. The principle difference between the FemRx™ Morcellator and the Storz device is that the FemRx device incorporates a fixed cylinder inside the rotating cutter (see figure below). The fixed (non rotating) cylinder located on the inside of the cutter is designed to reduce the torsional or rotational force applied to the cored tissue fragments as they are pulled up through the central lumen of the FemRx™ device. The FemRx™ Morcellator System also differs from the Storz device in that it is disposable and utilizes the Motor Drive Unit (MDU) that has been previously cleared as part of the FemRx™ OPERA STAR™ and TURP STAR™ Hysteroscopic and Urological Resectoscopic Systems [510(k) numbers K954648 and K962506]. All tissue contacting materials are standard medical grade and non-toxic. ![img-0.jpeg](img-0.jpeg) FemRx™ Morcellator ![img-1.jpeg](img-1.jpeg) Storz STEINER™ Morcellator 000004