510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K860511Substantially Equivalent

Ampu-Pak

Ammerman Medical Enterprises, Inc., Naples FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860511 is the FDA 510(k) clearance record for AMPU-PAK, cleared for Ammerman Medical Enterprises, Inc. on under FDA product code LPZ (Container, Frozen Donor Tissue Storage). FDA records list one 510(k) clearance for Ammerman Medical Enterprises, Inc. As of , FDA records show no recalls naming K860511.

Clearance record

Decision date
Received
(174 days to decision)
Product code
LPZ Container, Frozen Donor Tissue Storage
Device class
Unclassified
Review panel
Unknown
Applicant
Ammerman Medical Enterprises, Inc. 1180 Oleander Dr., Naples FL
Third party review
No

Clearances, product code LPZ

Trailing 12 months

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

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