510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K150852Substantially Equivalent

Sic 8000

Cosmo Technologies Ltd., Dublin 1, IE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K150852 is the FDA 510(k) clearance record for SIC 8000, a class II device, cleared for Cosmo Technologies, Ltd. on under FDA product code PLL (Submucosal Injection Agent). FDA's definition for product code PLL reads: "Intended for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or endoscopic device". FDA records list one 510(k) clearance for Cosmo Technologies, Ltd. As of , FDA records show no recalls naming K150852.

Clearance record

Decision date
Received
(156 days to decision)
Product code
PLL Submucosal Injection Agent
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Cosmo Technologies, Ltd. 42-43 Amiens St., Dublin 1, IE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PLL

Trailing 12 months
1 clearance under product code PLL in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PLL, 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 20261
October 20260