Essure is a permanent Birth Control System. One Essure Replacement Kit containing one pouched disposable delivery system with a wound-down insert and a valved introducer.

Essure is a permanent Birth Control System. One Essure Replacement Kit containing one pouched disposable delivery system with a wound
Essure - ESS305-R1

A small, sterile, implantable device that is implanted into the uterine end of the fallopian tubes (one device in each tube) to functions as a contraceptive through the obstruction of the natural fallopian tube passage. It typically consists of a micro insert with a stainless steel inner coil, a nickel-titanium alloy (Nitinol) "elastic" outer coil, and polyethylene (PE) fibres loaded into a delivery device. Upon placement and delivery, during a hysteroscopy, the device expands and anchors to the varied diameters and shapes of the fallopian tube and results in tubal occlusion by the PE fibres eliciting a tissue in-growth, this preventing the passage of ova.

No Data Available

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: HHS

Device Name: Transcervical Contraceptive Tubal Occlusion Device

Device Class: 3

Physical State: N/A

Definition: Call for PMAs 12/30/87 (52 FR 36883 10/1/87))

Submission Type ID: 2

Review Panel: OB

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: 884.5380

Third Party Flag: N

Medical Specialty: OB

Device Id: 00888853030517

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