510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K900908Substantially Equivalent

Controlled Distention Irrigation System Cdis 200

Zimmer GmbH, Dover OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K900908 is the FDA 510(k) clearance record for CONTROLLED DISTENTION IRRIGATION SYSTEM CDIS 200, a class II device, cleared for Zimmer, Inc. on under FDA product code HIG (Insufflator, Hysteroscopic). FDA records list 872 510(k) clearances for Zimmer, Inc., from to . As of , FDA records show no recalls naming K900908.

Clearance record

Decision date
Received
(83 days to decision)
Product code
HIG Insufflator, Hysteroscopic
Regulation
21 CFR 884.1700
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Zimmer, Inc. 200 W. Ohio Ave., Dover OH
Third party review
No

Clearances, product code HIG

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