510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K970482Substantially Equivalent

Transcom Colon Hydrotherapy Model Hc-2000

Srs Intl., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970482 is the FDA 510(k) clearance record for TRANSCOM COLON HYDROTHERAPY MODEL HC-2000, a class II device, cleared for Srs Intl. on under FDA product code KPL (Colonic Irrigation System). FDA records list one 510(k) clearance for Srs Intl. As of , FDA records show no recalls naming K970482.

Clearance record

Decision date
Received
(263 days to decision)
Product code
KPL Colonic Irrigation System
Regulation
21 CFR 876.5220
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Srs Intl. 1625 K St. NW, Washington DC
510(k) summary
Summary
Third party review
No

Clearances, product code KPL

Trailing 12 months

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

FDA records show no clearances under product code KPL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KPL, 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