510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K092097Substantially Equivalent

A.b. Korkor Medical Skinnysafe Introducer Sheath

A.B. Korkor Medical, Inc., North Barrington IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K092097 is the FDA 510(k) clearance record for A.B. KORKOR MEDICAL SKINNYSAFE INTRODUCER SHEATH, a class II device, cleared for A.B. Korkor Medical, Inc. on under FDA product code DYB (Introducer, Catheter). FDA records list one 510(k) clearance for A.B. Korkor Medical, Inc. As of , FDA records show no recalls naming K092097.

Clearance record

Decision date
Received
(296 days to decision)
Product code
DYB Introducer, Catheter
Regulation
21 CFR 870.1340
Device class
Class II
Review panel
Cardiovascular
Applicant
A.B. Korkor Medical, Inc. 400 N. Rand Rd., North Barrington IL
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code DYB

Trailing 12 months
18 clearances under product code DYB in the twelve months to October 2026, April 2026 the highest month at 7.
Show the numbers
Monthly 510(k) clearances under FDA product code DYB, trailing twelve months
MonthClearances
November 20250
December 20252
January 20261
February 20262
March 20261
April 20267
May 20260
June 20263
July 20262
August 20260
September 20260
October 20260