UNISILK— 510(k) K042282
Substantially EquivalentUnited Medical Industries Co. , Ltd.
FDA 510(k) clearance K042282 for UNISILK, Substantially Equivalent on 2004-12-01. Applicant: United Medical Industries Co. , Ltd.. Device class: 2.
Clearance details
- Applicant
- United Medical Industries Co. , Ltd.
- Product code
- Code GAP
- Device class
- Class 2
- Regulation
- 21 CFR 878.5030
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Riyadh, Central Province, SA
Recent devices under product code GAP
view all- K241486 — Sofsilk Coated Braided Silk Suture
- K222944 — SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture
- K232355 — Non absorbable Surgical Silk Suture
- K221767 — Surgical Sutures with or without Needle
- K180701 — SafePath Suturing System
More clearances from United Medical Industries Co. , Ltd.
view allAdverse events under product code GAP
product code GAP- Death
- 3
- Injury
- 491
- Malfunction
- 2,253
- Total
- 2,747
Source: openFDA MAUDE database, through . 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.