510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K070117Substantially Equivalent

Ssafe Plus Disposable Safety Syringe, 3 Cc and 5 Cc

Dolomite Biotech Sdn Bhd, San Leandro CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K070117 is the FDA 510(k) clearance record for SSAFE PLUS DISPOSABLE SAFETY SYRINGE, 3 CC AND 5 CC, a class II device, cleared for Dolomite Biotech Sdn Bhd on under FDA product code MEG (Syringe, Antistick). FDA records list one 510(k) clearance for Dolomite Biotech Sdn Bhd. As of , FDA records show no recalls naming K070117.

Clearance record

Decision date
Received
(206 days to decision)
Product code
MEG Syringe, Antistick
Regulation
21 CFR 880.5860
Device class
Class II
Review panel
General Hospital
Applicant
Dolomite Biotech Sdn Bhd 417 Whitney St., San Leandro CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MEG

Trailing 12 months
2 clearances under product code MEG 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 MEG, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260