510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K952563Substantially Equivalent

The Tulip Lci-200 Illumination & Imaging System

The Tulip Mfg. Co., Mesa AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K952563 is the FDA 510(k) clearance record for THE TULIP LCI-200 ILLUMINATION & IMAGING SYSTEM, a class II device, cleared for The Tulip Mfg. Co. on under FDA product code GCT (Light Source, Endoscope, Xenon Arc). FDA records list 24 510(k) clearances for The Tulip Mfg. Co., from to . As of , FDA records show no recalls naming K952563.

Clearance record

Decision date
Received
(53 days to decision)
Product code
GCT Light Source, Endoscope, Xenon Arc
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
The Tulip Mfg. Co. 40 W. Baseline Rd.,, Mesa AZ
510(k) summary
Summary
Third party review
No

Clearances, product code GCT

Trailing 12 months

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

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