510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K921228Substantially Equivalent

Benderev Protect-a-Pass Needle

Eimark Labs, Inc., Mission Viejo CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921228 is the FDA 510(k) clearance record for BENDEREV PROTECT-A-PASS NEEDLE, a class I device, cleared for Eimark Labs, Inc. on under FDA product code KOA (Surgical Instruments, G-U, Manual (And Accessories)). FDA records list one 510(k) clearance for Eimark Labs, Inc. As of , FDA records show no recalls naming K921228.

Clearance record

Decision date
Received
(185 days to decision)
Product code
KOA Surgical Instruments, G-U, Manual (And Accessories)
Regulation
21 CFR 876.4730
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Eimark Labs, Inc. 26732 Crown Valley Pkwy., Mission Viejo CA
510(k) summary
Statement
Third party review
No

Clearances, product code KOA

Trailing 12 months

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

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