510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K873109Substantially Equivalent

Model Cc-72 Cavernosometry/cavernosography Set

Life-Tech Intl., Inc., Houston TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K873109 is the FDA 510(k) clearance record for MODEL CC-72 CAVERNOSOMETRY/CAVERNOSOGRAPHY SET, a class II device, cleared for Life-Tech Intl., Inc. on under FDA product code OJA (Intravenous Extension Tubing Set). FDA's definition for product code OJA reads: "This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the...". FDA records list 68 510(k) clearances for Life-Tech Intl., Inc., from to . As of , FDA records show no recalls naming K873109.

Clearance record

Decision date
Received
(21 days to decision)
Product code
OJA Intravenous Extension Tubing Set
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Life-Tech Intl., Inc. P.O. Box 36221, Houston TX
Third party review
No

Clearances, product code OJA

Trailing 12 months

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

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