510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K062057Substantially Equivalent

U-Clip Device, Model Nc65

Medtronic, Inc., Minneapolis MN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K062057 is the FDA 510(k) clearance record for U-CLIP DEVICE, MODEL NC65, a class II device, cleared for Medtronic Vascular on under FDA product code FZP (Clip, Implantable). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K062057.

Clearance record

Decision date
Received
(13 days to decision)
Product code
FZP Clip, Implantable
Regulation
21 CFR 878.4300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Medtronic Vascular 7611 Northland Dr., Minneapolis MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FZP

Trailing 12 months
4 clearances under product code FZP in the twelve months to November 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FZP, trailing twelve months
MonthClearances
December 20252
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20261
October 20260
November 20260