510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K092022Substantially Equivalent

Tissu Trans Harvest Tubing

Summit Medical, LLC, Centennial CO / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K092022 is the FDA 510(k) clearance record for TISSU TRANS HARVEST TUBING, a class I device, cleared for Shippert Medical Technologies Corp. on under FDA product code KYZ (Syringe, Irrigating (Non Dental)). FDA records list 27 510(k) clearances for SUMMIT MEDICAL LLC, from to . As of , FDA records show no recalls naming K092022.

Clearance record

Decision date
Received
(42 days to decision)
Product code
KYZ Syringe, Irrigating (Non Dental)
Regulation
21 CFR 880.6960
Device class
Class I
Review panel
General Hospital
Applicant
Shippert Medical Technologies Corp. 6248 S. Troy Cir., Centennial CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KYZ

Trailing 12 months

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

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