Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar

FDA 510(k) K190029 · Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd

Substantially Equivalent

510(k) numberK190029

Submission

Device name
Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar
Applicant
Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd
Changzhou, CN
Received
January 7, 2019
Decision date
September 26, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GCJ – Laparoscope, General & Plastic Surgery
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Specialty
Gastroenterology, Urology

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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Questions and answers

When was Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar cleared by the FDA?

Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar (K190029) received a 510(k) decision of Substantially Equivalent on September 26, 2019, 262 days after the submission was received.

What is the product code of K190029?

The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.