510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K132389Substantially Equivalent

Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and Cystolflex F (Both Trade Marked

Daniel & Daniel Consulting, Orinda CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K132389 is the FDA 510(k) clearance record for CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES; UROFLEX B AND CYSTOLFLEX F (BOTH TRADE MARKED, a class II device, cleared for Daniel & Daniel Consulting on under FDA product code OWN (Confocal Optical Imaging). FDA's definition for product code OWN reads: "Collection of light signals for visualization of cellular microstructures". FDA records list one 510(k) clearance for Daniel & Daniel Consulting. As of , FDA records show no recalls naming K132389.

Clearance record

Decision date
Received
(208 days to decision)
Product code
OWN Confocal Optical Imaging
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Daniel & Daniel Consulting 8 Snowberry Ct., Orinda CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OWN

Trailing 12 months
8 clearances under product code OWN in the twelve months to October 2026, February 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code OWN, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20264
March 20260
April 20261
May 20260
June 20260
July 20261
August 20260
September 20261
October 20260