510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K993777Substantially Equivalent

Disposable and Reusable Ball and Loop Electrodes

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

K993777 is the FDA 510(k) clearance record for DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES, a class II device, cleared for R-Group Intl. on under FDA product code HGI (Electrocautery, Gynecologic (And Accessories)). FDA records list 7 510(k) clearances for R-Group Intl., from to . As of , FDA records show no recalls naming K993777.

Clearance record

Decision date
Received
(199 days to decision)
Product code
HGI Electrocautery, Gynecologic (And Accessories)
Regulation
21 CFR 884.4120
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
R-Group Intl. 2321 NW 66th Ct., Suite W-4, Gainesville FL
510(k) summary
Statement
Third party review
No

Clearances, product code HGI

Trailing 12 months

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

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