510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K220434Substantially Equivalent

Blue Eye (TS-905)

The Standard Co., Ltd., Gunpo-Si, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K220434 is the FDA 510(k) clearance record for Blue Eye (TS-905), a class II device, cleared for The Standard Co., 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 2 510(k) clearances for The Standard Co., Ltd., from to . As of , FDA records show no recalls naming K220434.

Clearance record

Decision date
Received
(178 days to decision)
Product code
PLL Submucosal Injection Agent
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
The Standard Co., Ltd. 120, Gunpocheomdansaneop 2-Ro, Gunpo-Si, KR
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