SEALING CAP

SEALING CAP - MAJ-2026

A small device intended to create a seal between a laparoscopic access cannula (not included) and an appropriately sized laparoscopic instrument, to inhibit the leakage of insufflation media [e.g., carbon dioxide (CO2) gas]. It is intended to be fitted directly to the proximal end of the sleeve and is typically available in a variety of sizes appropriate for given sleeve/instrument diameters. This is a reusable device intended to be sterilized prior to use.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

• Moist Heat or Steam Sterilization
• Ethylene Oxide
• High-level Disinfectant

Code: NWV

Device Name: Laparoscopic Accessories, Gynecologic

Device Class: 1

Physical State: Metal instruments

Definition: Exempt laparoscope accessories are non-powered, non-inflatable, simple manual mechanical devices, e.g., cannula, graspers, forceps, dissectors, scissors, etc. 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.

Submission Type ID: 4

Review Panel: OB

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Part of a system where the accessories advance the working channel of the laparoscope to perform it's function.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Abdominal cavity.

Regulation Number: 884.1720

Third Party Flag: N

Medical Specialty: OB

Device Id: 04953170332883

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A