510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K980980Substantially Equivalent

Motility Probe Model Numbers P31 Thru P38, P40 Thru P43 and P50

Konigsberg Instruments, Inc., Pasadena CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980980 is the FDA 510(k) clearance record for MOTILITY PROBE MODEL NUMBERS P31 THRU P38, P40 THRU P43 AND P50, a class II device, cleared for Konigsberg Instruments, Inc. on under FDA product code FFX (System, Gastrointestinal Motility (Electrical)). FDA records list 3 510(k) clearances for Konigsberg Instruments, Inc., from to . As of , FDA records show no recalls naming K980980.

Clearance record

Decision date
Received
(90 days to decision)
Product code
FFX System, Gastrointestinal Motility (Electrical)
Regulation
21 CFR 876.1725
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Konigsberg Instruments, Inc. 2000 Foothill Blvd., Pasadena CA
510(k) summary
Statement
Third party review
No

Clearances, product code FFX

Trailing 12 months
2 clearances under product code FFX 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 FFX, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260