510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K253199Substantially Equivalent

Curasys 2 (Emdn0003)

CG Bio Co., Ltd., Seoul, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K253199 is the FDA 510(k) clearance record for CURASYS 2 (EMDN0003), a class II device, cleared for CG Bio Co., Ltd. on under FDA product code OMP (Negative Pressure Wound Therapy Powered Suction Pump). FDA's definition for product code OMP reads: "For wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The Device is indicated for management of...". FDA records list 6 510(k) clearances for CG Bio Co., Ltd., from to . As of , FDA records show no recalls naming K253199.

Clearance record

Decision date
Received
(270 days to decision)
Product code
OMP Negative Pressure Wound Therapy Powered Suction Pump
Regulation
21 CFR 878.4780
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
CG Bio Co., Ltd. 1, Sangwon 12-Gil, Seongdong-Gu, Seoul, KR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OMP

Trailing 12 months
8 clearances under product code OMP in the twelve months to October 2026, May 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code OMP, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20261
April 20260
May 20263
June 20262
July 20260
August 20260
September 20261
October 20260