510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K897095Substantially Equivalent

Disposineedle Sharps Disposal Unit

Specialites Septodont, Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K897095 is the FDA 510(k) clearance record for DISPOSINEEDLE SHARPS DISPOSAL UNIT, a class II device, cleared for Specialites Septodont on under FDA product code MMK (Container, Sharps). FDA records list 21 510(k) clearances for Specialites Septodont, from to . As of , FDA records show no recalls naming K897095.

Clearance record

Decision date
Received
(27 days to decision)
Product code
MMK Container, Sharps
Regulation
21 CFR 880.5570
Device class
Class II
Review panel
General Hospital
Applicant
Specialites Septodont Washington Sq., Washington DC
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