DIAMOND-TOUCH AND MICRO DIAMOND-TOUCH INSTRUMENTS/DIAMOND-LINE INSTRUMENTS/DIAMOND-PORT(ACCESS PARTS)
Device Facts
| Record ID | K960400 |
|---|---|
| Device Name | DIAMOND-TOUCH AND MICRO DIAMOND-TOUCH INSTRUMENTS/DIAMOND-LINE INSTRUMENTS/DIAMOND-PORT(ACCESS PARTS) |
| Applicant | Snowden-Pencer |
| Product Code | FBM · Gastroenterology, Urology |
| Decision Date | Mar 12, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.5090 |
| Device Class | Class 1 |
| Attributes | Therapeutic |
Intended Use
Various endoscopic surgical instruments for use in minimally invasive cardiac procedures including single bypass and multiple bypass (coronary artery bypass grafting (CABG)procedures), and saphenous vein harvesting.
Device Story
Reusable endoscopic surgical instruments for minimally invasive cardiac surgery; includes endoscopes, needle holders, graspers, clamps, scissors, knife handles, hooks, clip appliers, irrigation/aspiration probes, electrodes, retractors, rib spreaders, thoraports, and cannulas. Used by surgeons in clinical/OR settings to facilitate access and manipulation during CABG and vein harvesting. Devices function as manual surgical tools; provide visualization and mechanical tissue interaction. Benefit: enables minimally invasive approach for cardiac procedures, reducing surgical trauma compared to open techniques.
Clinical Evidence
Bench testing only; no clinical data provided. Equivalence established via comparison of materials, design, and performance standards to predicate devices.
Technological Characteristics
Materials: stainless steel, titanium, rigid/flexible plastics, insulation. Design: manual endoscopic instruments (graspers, scissors, retractors, etc.). Energy: electrosurgical connections on specific models. Sterilization: reusable. Connectivity: none.
Indications for Use
Indicated for patients undergoing minimally invasive cardiac procedures, including single or multiple coronary artery bypass grafting (CABG) and saphenous vein harvesting.
Regulatory Classification
Identification
A suprapubic urological catheter and accessories is a flexible tubular device that is inserted through the abdominal wall into the urinary bladder with the aid of a trocar and cannula. The device is used to pass fluids to and from the urinary tract. This generic type of device includes the suprapubic catheter and tube, Malecot catheter, catheter punch instrument, suprapubic drainage tube, and the suprapubic cannula and trocar.
Predicate Devices
- Snowden-Pencer Reusable Laparoscopic/Endoscopic Surgical Instruments with Electrosurgical Connections and Accessories (K930666)
- Snowden-Pencer Reusable Laparoscopic/Endoscopic Surgical Instruments for General Surgery, and Plastic and Reconstructive Surgery, Including Aesthetic Surgery (K930667)
Related Devices
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- K973068 — KSEA INSTRUMENT SET FOR SAPHENOUS VEIN HARVESTING · Karl Storz Endoskop GmbH · Nov 7, 1997
- K970949 — SMITH & NEPHEW MIS INSTRUMENTS · Smith & Nephew Endoscopy, Inc. · Apr 23, 1997
- K181173 — ELMED Laparoscopic Instruments and Accessories · Elmed Incorporated · Mar 22, 2019
- K132645 — THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES · Medtronic, Inc. · Oct 4, 2013
