One Wall Puncture Needle

No FDA recalls on record, checked 22 Oct 2026.

Full name

R-Group Intl. One Wall Puncture Needle

510(k) Number

K913267 ↗

FDA Product Code

DRC

Device Class

Class II

Regulation

21 CFR Part 870.1390

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Acti-Flex Low, Medium, Rescare I, Rescare Ii.

  Class I

  FDA 510(k) K952470 Active Cleared 28 Nov 1995

• Acti-Flex Fluid Delivery System or Acti-Flex F D S

  Class II

  FDA 510(k) K001233 Active Cleared 13 Dec 2000

• Acti-Flex Arterial Extension Set

  Class I

  FDA 510(k) K954035 Active Cleared 25 Sep 1995

• Disposable And Reusable Ball And Loop Electrodes

  Class II

  FDA 510(k) K993777 Active Cleared 25 May 2000

• Acti-Flex Iv Administration Set

  Class II

  FDA 510(k) K001599 Active Cleared 18 Sep 2000

• R-Group International Coiled Low Pressure Extension Line

  Class II

  FDA 510(k) K940319 Active Cleared 10 Nov 1994

• What types of procedures is the R-Group International One Wall Puncture Needle designed for, and why is it considered a trocar?

  The R-Group International One Wall Puncture Needle is specifically designed for creating precise entry points into sealed or pressurized areas, such as those found in cardiovascular procedures. As a trocar, it is engineered to minimize trauma to surrounding tissues while accessing body cavities or vessel walls, making it suitable for controlled clinical settings like operating rooms or catheterization labs.

• Is this device intended for reuse, or is it meant for single-use only? How does this affect its clinical use?

  The device is explicitly intended for single-use only in controlled clinical settings. This design ensures patient safety by eliminating the risk of cross-contamination or degradation from repeated sterilization processes, which is critical in sterile environments like operating rooms or catheterization labs.

• What regulatory pathway was followed for this device’s clearance, and what does that mean for its use in clinical settings?

  The device received 510(k) clearance (K913267) under the FDA’s traditional review pathway, determined to be *substantially equivalent* to a predicate device. This means it has been evaluated for safety and effectiveness in cardiovascular applications and meets FDA standards for Class II devices (product code: DRC). Clinicians can rely on this clearance as evidence of regulatory scrutiny before use in procedures.

• Are there different sizes or models available for this puncture needle, and how might that impact procedure selection?

  While the provided data does not specify exact sizes or model variations, the device is categorized under OpenFDA’s product codes (e.g., 3009750712, 3008452825) and registration numbers, which often correlate with variations in gauge, length, or tip design. Clinicians should confirm the specific model’s dimensions with the manufacturer to ensure compatibility with the patient’s anatomy and procedural requirements.

• How should this device be stored, and what considerations should be taken into account before use?

  The data does not specify storage conditions, but as a single-use, sterile surgical instrument, it should be stored in a clean, dry environment protected from contamination, moisture, and extreme temperatures. Before use, verify the packaging is intact and the expiration date has not passed to ensure sterility and functionality, as required for sterile procedures.