510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K062720Substantially Equivalent

S-Line Bipolar Resectoscopes and Bipolar Electrodes

Richard Wolf Medical Instruments Corp., Vernon Hills IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K062720 is the FDA 510(k) clearance record for S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES, a class II device, cleared for Richard Wolf Medical Instruments Corp. on under FDA product code FJL (Resectoscope). FDA records list 153 510(k) clearances for Richard Wolf Medical Instruments Corp., from to . As of , FDA records show 2 recalls naming K062720.

Clearance record

Decision date
Received
(191 days to decision)
Product code
FJL Resectoscope
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Richard Wolf Medical Instruments Corp. 353 Corporate Woods Pkwy., Vernon Hills IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FJL

Trailing 12 months

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

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