510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K170513Substantially Equivalent

MAUSER PG II Sharps Container

Mauzer USA, LLC, East Brunswick NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K170513 is the FDA 510(k) clearance record for MAUSER PG II Sharps Container, a class II device, cleared for Mauzer USA, LLC on under FDA product code MMK (Container, Sharps). FDA records list one 510(k) clearance for Mauzer USA, LLC. As of , FDA records show no recalls naming K170513.

Clearance record

Decision date
Received
(253 days to decision)
Product code
MMK Container, Sharps
Regulation
21 CFR 880.5570
Device class
Class II
Review panel
General Hospital
Applicant
Mauzer USA, LLC 2 Tower Center Dr., 20th Floor, East Brunswick NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MMK

Trailing 12 months
3 clearances under product code MMK in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MMK, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20261
September 20260
October 20260