3-CCD Digital Camera

FDA 510(k) K970605 · Envision Medical Corp.

Substantially Equivalent

510(k) numberK970605

Submission

Device name
3-CCD Digital Camera
Applicant
Envision Medical Corp.
Santa Barbara, CA, US
Received
February 18, 1997
Decision date
May 22, 1997
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 3-CCD Digital Camera cleared by the FDA?

3-CCD Digital Camera (K970605) received a 510(k) decision of Substantially Equivalent on May 22, 1997, 93 days after the submission was received.

What is the product code of K970605?

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