Precise Flexistapler Circular Stapler, Series 398X

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

510(k) Number

K910897 ↗

FDA Product Code

GDW

Device Class

Class II

Regulation

21 CFR Part 878.4750

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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• What types of surgical procedures is the Precise Flexistapler Circular Stapler, Series 398X, primarily used for?

  The Precise Flexistapler Circular Stapler, Series 398X, is designed specifically for surgical anastomosis, which means it joins tissue sections together. It is particularly suited for creating precise and secure closures of tubular structures like the intestine or colon during general and plastic surgery procedures.

• Is the Precise Flexistapler Circular Stapler, Series 398X, intended for single-use or repeated use?

  The Precise Flexistapler Circular Stapler, Series 398X, is explicitly intended for single-use in controlled surgical environments. This ensures sterility and safety, as reuse is not authorized or recommended.

• How should the Precise Flexistapler Circular Stapler, Series 398X, be handled to maintain sterility?

  The device requires sterile handling due to its single-use nature. It must be kept in its original packaging until immediately before use, and any exposure to non-sterile environments should be avoided to prevent contamination.

• What regulatory pathway was followed for the FDA clearance of the Precise Flexistapler Circular Stapler, Series 398X?

  The Precise Flexistapler Circular Stapler, Series 398X, received FDA clearance through a 510(k) submission, specifically under the Traditional pathway. It was determined to be Substantially Equivalent (SESE) to a predicate device in 1991, with the clearance number K910897.

• Can the Precise Flexistapler Circular Stapler, Series 398X, be used in MRI environments?

  No, the Precise Flexistapler Circular Stapler, Series 398X, is not MRI-compatible. This means it should not be used in or near MRI machines, as it could interfere with imaging or pose safety risks.