Disposable Circular Stapler, Models Why-25, Why-29. Why 32

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls on record, checked 22 Oct 2026.

Trade Name

Disposable Circular Stapler

Model / Reference

WHY-29-D, 12001029, WHY-25-C, 12001025

FDA applicant

Changzhou Waston Medical Appliance Co., Ltd.

Primary DI / UDI-DI

06936594499934, 06936594499958

Basic UDI-DI

B-06936594499934, B-06936594499958

510(k) Number

K100386 ↗

FDA Product Code

GDW

EMDN Code

H0202020101 Single-use straight circular staplers for open surgery

Device Class

Class IIb EUDAMED

Class II 510(k)

Regulation

21 CFR Part 878.4750

Market of Registration

Spain

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Swing Forceps For Reduction Screws (5.5)

  Class I

  CE/MDD

• Large Compressing Clamp(Straight)

  Class I

  CE/MDD

• Locking Screw Wrench (Hex/SW5)

  Class I

  CE/MDD

• Multi-axial Screwdriver (Hex / SW2.5)

  Class I

  CE/MDD

• Instrument Case

  Class I

  CE/MDD

• Hollow Tap (Ø7.5)

  Class I

  CE/MDD

See all devices from Changzhou Waston Medical Appliance Co., Ltd →

• What types of surgical procedures are these circular staplers primarily used for?

  These disposable circular staplers (models WHY-25, WHY-29, and WHY-32) are designed for general and plastic surgery procedures requiring precise tissue approximation and closure. They create end-to-end or end-to-side anastomoses in the alimentary tract, meaning they are used to surgically connect or resect sections of the digestive tract, such as during colorectal, gastric, or esophageal surgeries.

• Are these staplers reusable, or are they intended for single-use only?

  These staplers are explicitly designed for single-use only. Each model (WHY-25, WHY-29, WHY-32) is supplied in sterile packaging for one-time clinical application, and no reusable or reprocessed variants are available. This aligns with standard surgical practice to prevent contamination and ensure patient safety.

• How should these staplers be stored before use, and what precautions should be taken?

  The staplers are non-sterile when supplied but must be used in sterile surgical environments. They come in sterile packaging, so storage should follow standard sterile surgical instrument protocols—protecting them from moisture, dust, and physical damage until ready for use. Avoid exposure to extreme temperatures or direct sunlight, as this could compromise sterility or functionality.

• What regulatory pathways have these devices undergone, and how does that affect their use?

  These staplers are regulated under FDA 510(k) clearance (K100386) and the Medical Devices Directive (MDD). The clearance confirms they are *substantially equivalent* to a predicate device, meaning they meet FDA safety and performance requirements for staple, implantable devices. Clinicians can rely on this regulatory status to ensure compliance with surgical standards, though local regulations should always be verified before use.

• Are there different sizes or models available, and how do I choose the right one for a procedure?

  Yes, three models are available: WHY-25, WHY-29, and WHY-32, each distinguished by their unique reference codes. The choice depends on the anatomical site and tissue thickness being anastomosed. For example, smaller diameters (e.g., WHY-25) may suit narrower sections like the esophagus, while larger diameters (e.g., WHY-32) could be better for broader sections like the colon. Consult surgical guidelines or manufacturer specifications to match the model to the patient’s anatomy and procedural requirements.