SILK NONABSORBABLE SURGICAL SUTURES USP— 510(k) K960328
Substantially Equivalent for Some IndicationsR. K. Medical L. L. C.
FDA 510(k) clearance K960328 for SILK NONABSORBABLE SURGICAL SUTURES USP, Substantially Equivalent for Some Indications on 1996-03-04. Applicant: R. K. Medical L. L. C.. Device class: 2.
Clearance details
- Applicant
- R. K. Medical L. L. C.
- 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 for Some Indications
- Clearance type
- Traditional
- Location
- Mahwah, NJ, US
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 R. K. Medical L. L. C.
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.