EndoClot

FDA 510(k) K162197 · Endoclot Plus Co., Ltd.

Substantially Equivalent

510(k) numberK162197

Submission

Device name
EndoClot
Applicant
Endoclot Plus Co., Ltd.
Suzhou, CN
Received
August 5, 2016
Decision date
January 18, 2017
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 EndoClot cleared by the FDA?

EndoClot (K162197) received a 510(k) decision of Substantially Equivalent on January 18, 2017, 166 days after the submission was received.

What is the product code of K162197?

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