510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K821999Substantially Equivalent

Endoscopic Sclerotherapy Balloon

Retech, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K821999 is the FDA 510(k) clearance record for ENDOSCOPIC SCLEROTHERAPY BALLOON, a class II device, cleared for Retech on under FDA product code GCP (Endoscope, Ac-Powered And Accessories). FDA records list one 510(k) clearance for Retech. As of , FDA records show no recalls naming K821999.

Clearance record

Decision date
Received
(51 days to decision)
Product code
GCP Endoscope, Ac-Powered And Accessories
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Retech 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GCP

Trailing 12 months

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

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