510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K894363Substantially Equivalent

Uropump* Fluid Management System

Orthoconcept, Inc., Columbia SC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894363 is the FDA 510(k) clearance record for UROPUMP* FLUID MANAGEMENT SYSTEM, a class II device, cleared for Orthoconcept, Inc. on under FDA product code FDC (Resectoscope, Working Element). FDA records list 8 510(k) clearances for Orthoconcept, Inc., from to . As of , FDA records show no recalls naming K894363.

Clearance record

Decision date
Received
(28 days to decision)
Product code
FDC Resectoscope, Working Element
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Orthoconcept, Inc. 8 Cold Branch Ct., Columbia SC
Third party review
No

Clearances, product code FDC

Trailing 12 months

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

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