Lap Disc 120 X 120, Model LD111, Lap Disc 120 X 100, Model LD112, Lap Disc 70 X 70, Model LD113

FDA 510(k) K010870 · Ethicon Endo-Surgery, Inc.

Substantially Equivalent

510(k) numberK010870

Submission

Device name
Lap Disc 120 X 120, Model LD111, Lap Disc 120 X 100, Model LD112, Lap Disc 70 X 70, Model LD113
Applicant
Ethicon Endo-Surgery, Inc.
Cincinnati, OH, US
Received
March 23, 2001
Decision date
June 18, 2001
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 Lap Disc 120 X 120, Model LD111, Lap Disc 120 X 100, Model LD112, Lap Disc 70 X 70, Model LD113 cleared by the FDA?

Lap Disc 120 X 120, Model LD111, Lap Disc 120 X 100, Model LD112, Lap Disc 70 X 70, Model LD113 (K010870) received a 510(k) decision of Substantially Equivalent on June 18, 2001, 87 days after the submission was received.

What is the product code of K010870?

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