← Product Code [FBM](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FBM) · K960400 # DIAMOND-TOUCH AND MICRO DIAMOND-TOUCH INSTRUMENTS/DIAMOND-LINE INSTRUMENTS/DIAMOND-PORT(ACCESS PARTS) (K960400) _Snowden-Pencer · FBM · Mar 12, 1996 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FBM/K960400 ## Device Facts - **Applicant:** Snowden-Pencer - **Product Code:** [FBM](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FBM.md) - **Decision Date:** Mar 12, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.5090 - **Device Class:** Class 1 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## Indications for 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. ## Regulatory 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](/device/K930666.md)) - Snowden-Pencer Reusable Laparoscopic/Endoscopic Surgical Instruments for General Surgery, and Plastic and Reconstructive Surgery, Including Aesthetic Surgery ([K930667](/device/K930667.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} MAR 12 1996 510(k) Summary K930660 Submitter: Deknatel Snowden Pencer (DSP) 5175 South Royal Atlanta Drive Tucker, GA 30084 Phone: (770) 496-0952 Fax: (770) 934-8659 Contact: Julie A.K. Stephens Trade Name - Diamond-Touch® and Micro Diamond-Touch® Instruments; Diamond-Line® Instruments; Diamond Port (Access Ports); Endo CABG (TM Approval Pending); CARDIO Port (TM Approval Pending) Common Name - Endoscope and Accessories for Minimally Invasive Cardiovascular Surgery Classification Name - Endoscope and Accessories (per 21 CFR 876.1500) Equivalent Device - Snowden-Pencer 510(k) # K930666 - Reusable Laparoscopic/Endoscopic Surgical Instruments with Electrosurgical Connections and Accessories and Snowden-Pencer 510(k) # K930667 -- Reusable Laparoscopic/Endoscopic Surgical Instruments for General Surgery, and Plastic and Reconstructive Surgery, Including Aesthetic Surgery Device Description - The devices are separated into several groups: endoscopes, endoscopic needle holders, endoscopic graspers and clamps, endoscopic scissors, endoscopic knife blade handles, hooks and clip appliers, endoscopic irrigation/aspiration probes, endoscopic electrodes, retractors and rib spreaders, thoraports and cannulas. 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. Summary of Technical Characteristic Equivalence - The endoscopes and endoscopic surgical instruments for cardiac procedures will use equivalent materials (such as stainless steel, titanium, rigid and flexible plastics, and insulation) and use the same designs (same handles, tubes, and jaws) as our current marketed line of general and plastic surgery endoscopes and endoscopic surgical instruments. Summary of Performance Equivalence - The endoscopes and endoscopic surgical instruments for cardiac procedures will have equivalent performance standards to our currently marketed line of general and plastic surgery endoscopes and endoscopic surgical instruments. Exhibit 2 - Page 1 of 1 --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FBM/K960400](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FBM/K960400) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com