510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K131072Substantially Equivalent

Orchestra Hydrophilic Guidewire Standard Angled, Orchestra Hydrophilic Guidewire Straight Stiff, Orchestra Hydrophilic

MEDLINE INDUSTRIES, LP - Northfield, Plymouth MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K131072 is the FDA 510(k) clearance record for ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILIC, a class II device, cleared for Coloplast A/S on under FDA product code OCY (Endoscopic Guidewire, Gastroenterology-Urology). FDA's definition for product code OCY reads: "To provide access to gi or gu tract for the purpose of passing or exchanging other accessories". FDA records list 414 510(k) clearances for MEDLINE INDUSTRIES, LP - Northfield, from to . As of , FDA records show no recalls naming K131072.

Clearance record

Decision date
Received
(83 days to decision)
Product code
OCY Endoscopic Guidewire, Gastroenterology-Urology
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Coloplast A/S 1601 W. River Rd. N., Plymouth MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OCY

Trailing 12 months

FDA records hold no clearances under product code OCY in the trailing twelve months.

FDA records show no clearances under product code OCY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OCY, 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 20260
October 20260