Cleared Special

PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E

K230991 · Given Imaging Ltd. (Medtronic) · Gastroenterology & Urology

Jun 2023

Decision

85d

Days

Class 2

Risk

About This 510(k) Submission

K230991 is an FDA 510(k) clearance for the PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E, a System, Imaging, Gastrointestinal, Wireless, Capsule (Class II — Special Controls, product code NEZ), submitted by Given Imaging Ltd. (Medtronic) (Yoqneam Northern, IL). The FDA issued a Cleared decision on June 30, 2023, 85 days after receiving the submission on April 6, 2023. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1300.

Submission Details

510(k) Number	K230991 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 06, 2023
Decision Date	June 30, 2023
Days to Decision	85 days
Submission Type	Special
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF