ab medica irrigation/suction gravity system

FDA 510(k) K151822 · Ab Medica Sas

Substantially Equivalent

510(k) numberK151822

Submission

Device name
ab medica irrigation/suction gravity system
Applicant
Ab Medica Sas
Mary-Su-Cher, FR
Received
July 6, 2015
Decision date
September 4, 2015
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 ab medica irrigation/suction gravity system cleared by the FDA?

ab medica irrigation/suction gravity system (K151822) received a 510(k) decision of Substantially Equivalent on September 4, 2015, 60 days after the submission was received.

What is the product code of K151822?

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