Surgical Scissors – Straight/Tapered Tip & Blunt/Blunt Tip, 10.5 cm, RWD S14001-10

Overview

The RWD S14001-10 Surgical Scissors are precision-engineered stainless steel cutting instruments designed for controlled tissue dissection, suture trimming, and delicate surgical manipulation in human and veterinary operating rooms, research laboratories, and preclinical animal surgery suites. Constructed from high-grade austenitic stainless steel (AISI 420 or equivalent), these scissors utilize a traditional scissor geometry based on the principle of two pivoted levers applying opposing shear forces at the blade tips—ensuring clean, low-friction cuts with minimal tissue drag. The dual-tip configuration—offering both straight/tapered (sharp/sharp) and blunt/blunt variants—supports functional versatility across soft tissue handling, fascial layer separation, and non-traumatic cutting where edge control and tactile feedback are critical. Designed to meet ISO 7740:2021 (Surgical Instruments — Requirements for Materials and Construction) and conforming to YY/T 0171–2020 (Chinese National Standard for Surgical Instruments), the S14001-10 integrates ergonomic handle geometry with a 10.5 cm overall length optimized for fingertip dexterity and wrist-neutral positioning during prolonged procedures.

Key Features

• Precision-forged, corrosion-resistant stainless steel blades with mirror-polished cutting edges for consistent sharpness retention and ease of sterilization via autoclaving (134 °C, 3 bar, 5–10 min cycles).
• Ergonomic ring handles with micro-textured surface finish to enhance grip stability under wet or gloved conditions.
• True 10.5 cm overall length (±0.5 mm tolerance), balancing maneuverability in confined anatomical fields with sufficient leverage for controlled cutting force application.
• Two interchangeable tip configurations: (1) Straight/tapered tip (sharp/sharp) for fine dissection and suture cutting; (2) Blunt/blunt tip for atraumatic tissue spreading and blunt dissection without puncture risk.
• Internally tensioned pivot screw assembly ensuring uniform blade alignment and reproducible cutting performance over ≥500 sterilization cycles.
• Compliant with ISO 13485:2016 quality management system requirements for medical device manufacturers.

Sample Compatibility & Compliance

The S14001-10 is intended for use with biological tissues—including skin, muscle, fascia, vessels, and connective membranes—across open, laparoscopic-assisted, and microsurgical workflows. It is not intended for bone, calcified tissue, or synthetic mesh cutting. All materials comply with ISO 10993-1:2018 (Biological evaluation of medical devices) for cytotoxicity, sensitization, and intracutaneous reactivity. Device labeling adheres to UDI (Unique Device Identification) requirements per FDA 21 CFR Part 830 and EU MDR Annex I essential requirements. Sterilization validation data supports steam sterilization (EN 285), ethylene oxide (ISO 11135), and low-temperature hydrogen peroxide plasma (ISO 14937). Batch traceability is maintained through laser-engraved model number and serial identifier on the shank.

Software & Data Management

As a Class I non-powered, manually operated surgical instrument, the S14001-10 does not incorporate embedded electronics, firmware, or software interfaces. However, its design supports full integration into digital perioperative documentation systems: each unit carries a permanent laser-marked identifier enabling traceability within hospital asset management platforms (e.g., RFID-enabled inventory modules or barcode-scanned OR logs). RWD provides comprehensive technical documentation—including IFU (Instructions for Use), sterilization protocols, and material declarations—in English and aligned with ISO 15223-1:2021 symbols for global regulatory submission support. Audit-ready manufacturing records and sterilization validation summaries are available upon request for GLP/GCP-compliant preclinical study reporting.

Applications

• General surgery: Layer-by-layer dissection during abdominal, thoracic, and soft-tissue procedures.
• Veterinary surgery: Rodent, rabbit, and canine models requiring precise incision control and minimal collateral trauma.
• Neuroscience research: Craniotomy site preparation, dural opening, and electrode lead trimming in stereotaxic surgery.
• Pathology specimen processing: Tissue sectioning, margin trimming, and organ dissection prior to fixation.
• Teaching laboratories: Student training in aseptic technique, instrument handling, and basic surgical skills acquisition.

FAQ

What sterilization methods are validated for the S14001-10?

Autoclaving (steam under pressure), ethylene oxide gas, and low-temperature hydrogen peroxide plasma are all validated per ISO 17664-1:2017.
Is this instrument certified for clinical use in the EU or USA?

The S14001-10 carries CE marking under MDR 2017/745 as a Class I sterile/non-sterile surgical instrument; FDA listing is active under 510(k) exemption pathway (21 CFR 878.4490).
Can the scissors be sharpened after repeated use?

Yes—RWD recommends professional sharpening using diamond-coated hones calibrated to original 12°–15° bevel angles; user sharpening is not advised due to risk of geometry distortion.
What is the expected service life under routine sterilization?

When maintained per IFU, the instrument retains functional integrity for ≥500 autoclave cycles or 3 years of average clinical use, whichever occurs first.
Does RWD provide OEM/private-label options for this model?

Yes—custom engraving, packaging, and documentation localization are available under ISO 13485-compliant OEM agreements.