510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K920574Substantially Equivalent

Camsys 6300

F.M. Wiest USA, Inc., Oradell NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K920574 is the FDA 510(k) clearance record for CAMSYS 6300, a class II device, cleared for F.M. Wiest USA, Inc. on under FDA product code EXQ (Cystometer, Electrical Recording). FDA records list 12 510(k) clearances for F.M. Wiest USA, Inc., from to . As of , FDA records show no recalls naming K920574.

Clearance record

Decision date
Received
(376 days to decision)
Product code
EXQ Cystometer, Electrical Recording
Regulation
21 CFR 876.1620
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
F.M. Wiest USA, Inc. 690 Kinderkamack Rd., 1st Floor, Oradell NJ
510(k) summary
Summary
Third party review
No

Clearances, product code EXQ

Trailing 12 months
1 clearance under product code EXQ in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code EXQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260