Oratec SpineCath Intradiscal Catheter

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K974464 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Modification to Tac-S Monopolar Cautery Probe Family

  Class II

  FDA 510(k) K984185 Active Cleared 16 Dec 1998

• Oratec Interventions Vulcan Eas Electrothermal Arthroscopy System and Accessories

  Class II

  FDA 510(k) K991140 Active Cleared 25 Oct 1999

• Vulcan Ablator Electrosurgical Probes, Vulcan Ligament Chisel Electrosurgical Probes, Model 91000X, 91002X, 91300X

  Class II

  FDA 510(k) K003893 Active Cleared 1 Mar 2001

• Vulcan Electrosurgical Probes: Vulcan Micro Ligament Chisels, Vulcan Ligament Chisels, Vulcan Eflex Ligament Chisels

  Class II

  FDA 510(k) K000691 Active Cleared 4 May 2000

• Deflectable Tac Electrothermal Probe

  Class II

  FDA 510(k) K990859 Active Cleared 14 Jun 1999

• Oratec Interventiouns Electrosurgical Probes

  Class II

  FDA 510(k) K965007 Active Cleared 6 Feb 1997

See all devices from Oratec Interventions, Inc. →

• What is the primary clinical purpose of the Oratec SpineCath Intradiscal Catheter, and who should use it?

  The Oratec SpineCath Intradiscal Catheter is designed for coagulation and decompression of disc material within the intervertebral disc space. It is intended for symptomatic patients with annular disruption of contained herniated discs, helping to relieve pressure and pain by targeting the affected disc. Due to its specialized use, it should only be used by trained professionals in a clinical setting, such as interventional spine specialists or surgeons experienced in disc interventions.

• Is the Oratec SpineCath Intradiscal Catheter meant for single-use or reusable applications, and how is it supplied?

  The device is explicitly labeled as a single-use, sterile instrument, meaning it is intended for one-time clinical use only. It is supplied pre-sterilized and packaged for immediate use in a sterile field, ensuring safety and compliance with infection control protocols. Reuse is not recommended unless explicitly authorized by the manufacturer’s instructions, which are not detailed in the provided data.

• How is the regulatory status of this device determined, and what does the FDA’s 510(k) clearance mean for its use?

  The Oratec SpineCath Intradiscal Catheter received FDA clearance through the 510(k) pathway, specifically under K974464, with a decision dated March 19, 1998. This clearance categorizes it as substantially equivalent to a predicate device already on the market, meaning the FDA determined it meets the same safety and effectiveness standards. Clinically, this means it is legally marketable in the U.S. for its intended use in coagulation and decompression of herniated discs, but it does not imply broader indications beyond what is explicitly stated in the device description.

• Are there different sizes or models of the Oratec SpineCath Intradiscal Catheter, and if so, how might they be differentiated?

  The provided data does not specify distinct sizes or models of the Oratec SpineCath Intradiscal Catheter. However, intradiscal catheters like this often vary by length, diameter, or catheter tip design to accommodate different anatomical or procedural needs. For precise sizing or model selection, clinicians should refer to the manufacturer’s product catalog or technical documentation, as these details are not included in the regulatory submission data.