Laparoscopic Single Port Access Device

Device Code: 5464

Product Code(s): OTJ

Definition: A Multiple Instrument And/or Camera Port During Minimally Invasive Abdominal Laparoscopic Surgery.

Device Classification Information

• Device Type ID: 5464
• Device Name: Laparoscopic Single Port Access Device
• Physical State: Multiple Laparoscopic Trocars And Insufflation Tube(s) Bound By A Flexible Foam Port.
• Technical Method: This Device Utilizes Multiple Laparoscopic Trocars And Insufflation Tube(s) Bound By A Flexible Foam Port. The Flexibility Of The Port Enables Laparoscopic Instruments To Be Moved At Different Angles Relative To Each Other.
• Target Area: Abdominal
• Regulation Description: Endoscope And Accessories.
• Regulation Medical Specialty: Gastroenterology/Urology
• Review Panel: General & Plastic Surgery
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Surgical Devices (DSD); General Surgery Devices Branch Two - Surgical (GSDB2)
• Submission Type: 510(k)
• CFR Regulation Number: 876.1500 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: OTJ
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 5464
• Device: Laparoscopic Single Port Access Device
• Product Code: OTJ
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Endoscope And Accessories.
• CFR Regulation Number: 876.1500 [🔎]

Premarket Reviews
Manufacturer	Decision
FORTIMEDIX SURGICAL B.V.
	SUBSTANTIALLY EQUIVALENT	1
NELIS
	SUBSTANTIALLY EQUIVALENT	1

TPLC Last Update: 2019-04-02 21:06:42