SUTUREMATE— 510(k) K926126

Name: FDA 510(k) clearance K926126
Creator: U.S. Food and Drug Administration
Published: 1993-05-19

Substantially Equivalent

Surgical Safety Products, Inc.

FDA 510(k) clearance K926126 for SUTUREMATE, Substantially Equivalent on 1993-05-19. Applicant: Surgical Safety Products, Inc.. Device class: 1.

Clearance details

Applicant: Surgical Safety Products, Inc.
Product code: Code MDM
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1992-12-04
Decision date: 1993-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MDM

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K073664 — FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER2008-08-08
K050575 — FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM2005-08-15
K050957 — EUTROCHAR2005-05-18
K023173 — ANDREWS INTRODUCER, MODEL ASI012002-12-18
K022059 — MICROVASIVE PULMONARY GUIDEWIRE2002-11-13

Adverse events under product code MDM

product code MDM

Injury: 247
Malfunction: 1,516
Total: 1,763

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.