510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K952470Substantially Equivalent

Acti-Flex Low, Medium, Rescare I, Rescare II.

R-Group Intl., Gainesville FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K952470 is the FDA 510(k) clearance record for ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II., a class I device, cleared for R-Group Intl. on under FDA product code GCD (Connector, Catheter). FDA records list 7 510(k) clearances for R-Group Intl., from to . As of , FDA records show no recalls naming K952470.

Clearance record

Decision date
Received
(186 days to decision)
Product code
GCD Connector, Catheter
Regulation
21 CFR 878.4200
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
R-Group Intl. P.O. Box 7235, Gainesville FL
510(k) summary
Summary
Third party review
No

Clearances, product code GCD

Trailing 12 months

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

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