SMB Luer lock disposable syringe— 510(k) K231558

Name: FDA 510(k) clearance K231558
Creator: U.S. Food and Drug Administration
Published: 2024-01-12

Substantially Equivalent

Smb Corporation of India

FDA 510(k) clearance K231558 for SMB Luer lock disposable syringe, Substantially Equivalent on 2024-01-12. Applicant: Smb Corporation of India. Device class: 2.

Clearance details

Applicant: Smb Corporation of India
Product code: Code FMF
Device class: Class 2
Regulation: 21 CFR 880.5860
Advisory panel: General Hospital
Date received: 2023-05-30
Decision date: 2024-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Valsad, IN

Download summary PDF View on FDA.gov ↗

Recent devices under product code FMF

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K262581 — GraftGun Universal Graft Delivery System (GDS®)2026-08-26
K252184 — SOL-M Luer Lock Syringe with Exchangeable Needle Tray2026-08-25
K253747 — Disposable Pen Injector (KXYC-03C02, KXYC-03A03)2026-08-14
K260208 — Ultra-Fine SAFETY Insulin Syringe2026-07-13
K253110 — Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe2026-06-18

Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.