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Grieshaber Scleral Buckling Balloon Catheter

FDA PMA

Class III (US FDA PMA)

PMA P930024

by Labtician Ophthalmics, Inc

Identity

Trade Name
GRIESHABER SCLERAL BUCKLING BALLOON CATHETER FDA PMA
Generic Name
Catheter, balloon for retinal reattachment FDA PMA

Identifiers

PMA Number
P930024 FDA PMA
FDA Product Code
LOG FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
Ophthalmic FDA PMA
FDA Decision
APWD FDA PMA

The Grieshaber Scleral Buckling Balloon Catheter is a catheter, balloon for retinal reattachment used in ophthalmic surgery. It is designed to assist in scleral buckling procedures by applying controlled pressure to the sclera to support retinal reattachment.

This device is supplied sterile and intended for single-use. It is used in surgical settings by ophthalmologists and has received FDA Premarket Approval (PMA) under number P930024. The device is classified as Class III and is indicated for use in retinal detachment repair.

Frequently asked questions

What is the primary medical use of the Grieshaber Scleral Buckling Balloon Catheter?

The device is used as a catheter, balloon for retinal reattachment in ophthalmic surgery, specifically to assist in scleral buckling procedures by applying pressure to the sclera to support retinal reattachment.

Is the Grieshaber Scleral Buckling Balloon Catheter reusable or single-use?

The device is supplied sterile and intended for single-use only, as indicated in the specifications and regulatory documentation.

What regulatory authorization does the Grieshaber Scleral Buckling Balloon Catheter have?

The device has received FDA Premarket Approval (PMA) under application number P930024, with a decision date of June 2, 1994, and is classified as a Class III medical device.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Labtician Ophthalmics, Inc
FDA Applicant
Labtician Ophthalmics, Inc.

Sources (1)

  • FDA PMA P930024 24 fields · synced Oct 6, 2026