510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K872860Substantially Equivalent

Insufflator Tubing

MEDLINE INDUSTRIES, LP - Northfield, Englewood CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K872860 is the FDA 510(k) clearance record for INSUFFLATOR TUBING, a class II device, cleared for Medline Industries, Inc. on under FDA product code HIG (Insufflator, Hysteroscopic). FDA records list 414 510(k) clearances for MEDLINE INDUSTRIES, LP - Northfield, from to . As of , FDA records show no recalls naming K872860.

Clearance record

Decision date
Received
(118 days to decision)
Product code
HIG Insufflator, Hysteroscopic
Regulation
21 CFR 884.1700
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Medline Industries, Inc. 99 Inverness Dr. E., Englewood CO
Third party review
No

Clearances, product code HIG

Trailing 12 months
2 clearances under product code HIG in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HIG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260