510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K791633Substantially Equivalent

Uc-2000 Uterine Catherization System

Life Support, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K791633 is the FDA 510(k) clearance record for UC-2000 UTERINE CATHERIZATION SYSTEM, a class II device, cleared for Life Support, Inc. on under FDA product code HFO (Recorder, Pressure, Intrauterine). FDA records list 2 510(k) clearances for Life Support, Inc., from to . As of , FDA records show no recalls naming K791633.

Clearance record

Decision date
Received
(27 days to decision)
Product code
HFO Recorder, Pressure, Intrauterine
Regulation
21 CFR 884.2700
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Life Support, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HFO

Trailing 12 months

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

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