Acufex Suretac PAC

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

Full name

Acufex Suretac(R) Pac

510(k) Number

K930538 ↗

FDA Product Code

JDR

Device Class

Class II

Regulation

21 CFR Part 888.3030

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Acufex Metal Acl Cannula

  Class II

  FDA 510(k) K932718 Active Cleared 21 Mar 1994

• Acufex Endofix Absorbable Interference Screw

  Class II

  FDA 510(k) K954246 Active Cleared 15 Feb 1996

• Acufex Arthroscopic Shoulder Guide System

  Class II

  FDA 510(k) K940481 Active Cleared 6 May 1994

• Acufex Arthroscopic Shaver

  Class I

  FDA 510(k) K844130 Active Cleared 21 Mar 1985

• Acufex Endobutton System

  Class II

  FDA 510(k) K933948 Active Cleared 21 Jul 1994

• Flouroshield Radiation Reduction Glove

  Class I

  FDA 510(k) K893093 Active Cleared 13 Feb 1990

See all devices from Acufex Microsurgical, Inc. →

• What types of vascular procedures is the Acufex Suretac PAC catheter specifically designed for, and how does it work in those settings?

  The Acufex Suretac PAC is designed for interventional radiology procedures where embolic agents need to be delivered to specific vascular targets. Its primary use is to occlude blood flow to lesions like uterine fibroids, helping to reduce their size by cutting off their blood supply. The catheter is inserted into the vascular system and guides embolic materials directly to the target area, ensuring precise delivery for effective treatment.

• Is the Acufex Suretac PAC catheter reusable, or is it intended for single-use only? How does this affect its clinical use?

  The Acufex Suretac PAC is explicitly intended for single-use only in controlled clinical settings. This design choice ensures sterility and safety, as reuse could compromise integrity and introduce infection risks. Clinicians must adhere to single-use protocols to maintain compliance with regulatory standards and patient safety.

• How is the Acufex Suretac PAC catheter supplied, and what should clinicians consider when handling or storing it?

  The device is supplied sterile by the manufacturer, which means it is pre-packaged and ready for immediate clinical use without additional sterilization. Clinicians should store it in a clean, dry environment, protected from extreme temperatures or physical damage, to preserve sterility and functionality until use. Always follow manufacturer guidelines for unpacking and handling to avoid contamination.

• What regulatory pathway does the Acufex Suretac PAC follow, and what does this mean for its use in clinical practice?

  The Acufex Suretac PAC was cleared through the FDA 510(k) process (K930538) under the Orthopedic advisory committee (OR) and classified as a Class II device with a product code of JDR (Embolization Catheter). This means it is considered substantially equivalent to a predicate device and adheres to traditional premarket notification requirements. Clinicians can rely on this clearance for its intended use in embolization procedures, though they should always verify current regulatory status before use.