510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K230991Substantially Equivalent

PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E

Given Imaging Ltd. (Medtronic), Yoqneam Northern, IL / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K230991 is the FDA 510(k) clearance record for PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E, a class II device, cleared for Given Imaging Ltd. (Medtronic) on under FDA product code NEZ (System, Imaging, Gastrointestinal, Wireless, Capsule). FDA records list 2 510(k) clearances for Given Imaging Ltd. (Medtronic), from to . As of , FDA records show no recalls naming K230991.

Clearance record

Decision date
Received
(85 days to decision)
Product code
NEZ System, Imaging, Gastrointestinal, Wireless, Capsule
Regulation
21 CFR 876.1300
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Given Imaging Ltd. (Medtronic) 2 Hacarmel St. New Industrial Park, Yoqneam Northern, IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NEZ

Trailing 12 months
2 clearances under product code NEZ in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NEZ, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260