Who is the manufacturer of KSEA UNIMAT PLUS?

KARL STORZ Endoscopy-America, Inc. submitted the Traditional clearance for KSEA UNIMAT PLUS (K962898).

What is the FDA product code for KSEA UNIMAT PLUS?

EOB. It is classified under 21 CFR 874.4760 as a Class 2 device in the Ear, Nose, Throat panel.

What is the regulatory pathway for KSEA UNIMAT PLUS?

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

KSEA UNIMAT PLUS

K962898 · KARL STORZ Endoscopy-America, Inc. · EOB · Aug 27, 1996 · Ear, Nose, Throat

Device Facts

Record ID	K962898
Device Name	KSEA UNIMAT PLUS
Applicant	KARL STORZ Endoscopy-America, Inc.
Product Code	EOB · Ear, Nose, Throat
Decision Date	Aug 27, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 874.4760
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Karl Storz Unimat Plus system is designed to provide irrigation and aspiration of the surgical site during general and endoscopic ENT surgical procedures.

Device Story

Membrane-type irrigation/aspiration pump; provides fixed flow rate of 3.5 L/min and maximum irrigation pressure of 400 mm Hg. Used in general and endoscopic ENT surgical procedures. Operated by surgical staff in clinical/OR settings. Facilitates site visualization and debris removal by managing fluid dynamics at the surgical site.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Membrane-type pump; fixed flow rate 3.5 L/min; max irrigation pressure 400 mm Hg.

Indications for Use

Indicated for irrigation and aspiration of surgical sites during general and endoscopic ENT surgical procedures in patients requiring such intervention.

Regulatory Classification

Identification

A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.

Related Devices

K963960 — KSEA UNIMAT PLUS · KARL STORZ Endoscopy-America, Inc. · Dec 20, 1996
K962090 — KARL STORZ MODEL 203210 O1 UNIMAT PLUS · KARL STORZ Endoscopy-America, Inc. · Sep 30, 1996
K963949 — KSEA UNIMAT PLUS · KARL STORZ Endoscopy-America, Inc. · Dec 19, 1996
K973286 — ENT IRRIGATING PUMP (70327700) · Gyrus Ent LLC · Sep 29, 1997
K040239 — SUPRAFLOW CONSOLE · Neomedix Corp. · Feb 17, 2004

Submission Summary (Full Text)

{0} K962898 AUG 27 1996 # 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 is accurate and complete to the best of KSEA's knowledge. **Applicant:** Karl Storz Endoscopy - America, Inc. 600 Corporate Pointe Drive Culver City, CA 90230 (310) 558-1500 **Contact:** Kevin Kennan Regulatory Affairs Specialist **Device Identification:** Common Name: Suction/irrigation Pump Trade Name: (optional) Karl Storz Unimat Plus **Indication:** The Karl Storz Unimat Plus system is designed to provide irrigation and aspiration of the surgical site during general and endoscopic ENT surgical procedures. **Device Description:** The Karl Storz Unimat Plus and accessories is a membrane type irrigation/aspiration pump with fixed irrigation/aspiration flow rate of 3.5 liters/min. and a maximum irrigation pressure of 400 mm Hg. **Substantial Equivalence:** The Karl Storz Unimat Plus system is substantially equivalent to the predicate devices since the basic features and intended uses are similar. The minor differences between the Karl Storz Unimat Plus and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices. Signed: Kevin Kennan Regulatory Affairs Specialist 000056