SEALING CAP

SEALING CAP - MAJ-2026

A small, noninvasive device intended to be fitted into the proximal end of a laparoscopic access cannula to create a seal between the cannula and an introduced laparoscopic instrument, for inhibition of insufflation gas leakage. 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