510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K092783Substantially Equivalent

Debp

Enko, Ltd., Cigli - Izmir, TR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K092783 is the FDA 510(k) clearance record for DEBP, a class II device, cleared for Enko , Ltd. on under FDA product code HGX (Pump, Breast, Powered). FDA records list one 510(k) clearance for Enko , Ltd. As of , FDA records show no recalls naming K092783.

Clearance record

Decision date
Received
(42 days to decision)
Product code
HGX Pump, Breast, Powered
Regulation
21 CFR 884.5160
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Enko , Ltd. 10006 Sokak, #64,, Cigli - Izmir, TR
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code HGX

Trailing 12 months
37 clearances under product code HGX in the twelve months to October 2026, April 2026 the highest month at 8.
Show the numbers
Monthly 510(k) clearances under FDA product code HGX, trailing twelve months
MonthClearances
November 20251
December 20253
January 20261
February 20264
March 20262
April 20268
May 20263
June 20268
July 20262
August 20262
September 20263
October 20260