510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K884920Substantially Equivalent

Rectum-Colon Motility Monitor

Multi-Spectrum Consulting, Inc., Holt MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K884920 is the FDA 510(k) clearance record for RECTUM-COLON MOTILITY MONITOR, a class II device, cleared for Multi-Spectrum Consulting, Inc. on under FDA product code FAP (Cystometric Gas (Carbon-Dioxide) On Hydraulic Device). FDA records list one 510(k) clearance for Multi-Spectrum Consulting, Inc. As of , FDA records show no recalls naming K884920.

Clearance record

Decision date
Received
(375 days to decision)
Product code
FAP Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
Regulation
21 CFR 876.1620
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Multi-Spectrum Consulting, Inc. 4649 Sycamore St., Holt MI
Third party review
No

Clearances, product code FAP

Trailing 12 months

FDA records hold no clearances under product code FAP in the trailing twelve months.

FDA records show no clearances under product code FAP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FAP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260