Adapt Laparoscopic Port & Adapt Reducer Cap

• • Terminated Z-1326-2014 FDA Class II ·initiated 11 Mar 2014

  Complaints of leakage of insufflation gas through the device.

• 2 recalls, same reason

  • Terminated Z-1279-2014 FDA Class II ·initiated 11 Mar 2014
  • Terminated Z-1284-2014 FDA Class II ·initiated 11 Mar 2014

  Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.

510(k) Number

K010007 ↗

FDA Product Code

GCJ

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• O.P.C. Intravascular Catheter

  Class II

  FDA 510(k) K875082 Active Cleared 8 Mar 1988

• Taut Balloon Catheter, Model 50640

  Class II

  FDA 510(k) K011018 Active Cleared 22 Jun 2001

• Tuat Splatter Control Shield Scs-300

  Class II

  FDA 510(k) K962003 Active Cleared 18 Jul 1996

• Adapt Open Access Port, Model 41233

  Class II

  FDA 510(k) K021731 Active Cleared 8 Aug 2002

• Taut-Insufflation Needle

  Class II

  FDA 510(k) K003703 Active Cleared 22 Feb 2001

• Mini-Port

  Class I

  FDA 510(k) K992904 Active Cleared 5 Oct 1999

See all devices from Taut, Inc. →

• What is the Adapt Laparoscopic Port & Adapt Reducer Cap used for?

  This device is designed for minimally invasive laparoscopic procedures, enabling secure trocar insertion and maintaining a gas seal to prevent air leaks. It supports a range of surgeries, including general, plastic, gastroenterology, and urology cases, by adapting to various trocar sizes via its reducer cap. The system ensures stability during insufflation, reducing the risk of complications from leaks or dislodged instruments.

• How is the Adapt Laparoscopic Port & Adapt Reducer Cap supplied and prepared for use?

  The device is supplied sterile and intended for single-use only, meaning it must not be reused after a single surgical procedure. To prepare it for use, follow standard sterile medical device protocols: open the packaging carefully to avoid contamination, inspect for damage, and ensure the reducer cap is securely attached if needed. Always adhere to manufacturer guidelines for proper handling and setup to maintain sterility and functionality.

• Can the reducer cap be used with all trocar sizes, or are there specific compatibility requirements?

  The reducer cap is included to enhance versatility by adapting the port to various trocar sizes, though exact compatibility depends on the specific trocar dimensions being used. While the design supports multiple sizes, clinicians should verify the reducer cap’s fit with their chosen trocar to ensure a proper seal and secure insertion. Refer to the manufacturer’s instructions for precise sizing guidance if uncertainty exists.

• What storage and handling precautions must be taken for this device?

  Since the Adapt Laparoscopic Port & Adapt Reducer Cap is sterile and single-use, it must be stored in its original, unopened packaging in a clean, dry environment protected from extreme temperatures, moisture, and direct sunlight. Avoid exposure to chemicals or contaminants that could compromise sterility. Once opened, the device should be used immediately, and any unused portions must be discarded per single-use guidelines to prevent infection risks.

• Is this device regulated under a specific pathway, and what does that mean for its use?

  The device is cleared under the FDA’s Traditional 510(k) pathway (K010007) as substantially equivalent to a predicate device, classified as Class 2 under product code GCJ. This pathway confirms the device meets FDA safety and performance standards for laparoscopic ports. Clinicians and users should ensure the device is used within its intended surgical contexts (e.g., gastroenterology, urology) and follow all labeling instructions to comply with regulatory requirements.