510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K051488Substantially Equivalent

Medicinelodge Zipknot

Medicinelodge, Inc., Logan UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K051488 is the FDA 510(k) clearance record for MEDICINELODGE ZIPKNOT, a class II device, cleared for Medicinelodge, Inc. on under FDA product code NVH (Suture, Knot, Mechanical). FDA's definition for product code NVH reads: "In approximation and/or ligation of soft tissue". FDA records list 8 510(k) clearances for Medicinelodge, Inc., from to . As of , FDA records show no recalls naming K051488.

Clearance record

Decision date
Received
(51 days to decision)
Product code
NVH Suture, Knot, Mechanical
Regulation
21 CFR 878.4300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Medicinelodge, Inc. 180 S. 600 W., Logan UT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NVH

Trailing 12 months

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

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