MICHEL Suture Removal Forceps – 13 cm

Overview

The MICHEL Suture Removal Forceps (Model R14005-13) is a precision-engineered, ergonomically designed surgical instrument intended for the safe, controlled, and atraumatic removal of non-absorbable sutures in clinical, veterinary, and research laboratory settings. Based on the classic Michel design—originally developed for ophthalmic and delicate dermatological procedures—this 13 cm forceps features fine-tipped, slightly curved jaws with micro-serrated gripping surfaces optimized to engage suture knots without slippage or tissue trauma. Its compact length ensures optimal maneuverability in confined anatomical spaces while maintaining sufficient leverage for secure suture grasp and clean extraction. Constructed from high-grade stainless steel (AISI 420 or equivalent), the instrument complies with ISO 7153-1:2016 for surgical instruments — materials and mechanical properties, and is fully autoclavable at 134 °C (273 °F) for repeated sterilization cycles under EN 285 and ISO 17664 standards.

Key Features

• 13 cm total length with balanced weight distribution (net weight: 39.8 g) for enhanced tactile control and reduced operator fatigue during prolonged use
• Fine, tapered tips with calibrated micro-serrations (pitch ≤ 0.15 mm) enabling secure engagement of 4-0 to 7-0 monofilament and braided sutures
• Smooth, seamless joint mechanism with zero play, engineered for long-term durability and consistent mechanical performance after ≥1,000 autoclave cycles
• Electropolished surface finish meeting ISO 13485–mandated biocompatibility requirements (ISO 10993-1 tested)
• Non-reflective satin finish to minimize glare under surgical lighting, supporting visual focus during critical wound inspection

Sample Compatibility & Compliance

The R14005-13 forceps is compatible with all standard non-absorbable suture materials including nylon (Ethilon®), polypropylene (Prolene®), silk, and stainless steel wire. It is routinely employed in postoperative care protocols aligned with WHO Surgical Safety Checklist recommendations and supports adherence to Joint Commission International (JCI) standards for sterile instrument handling. As a Class I medical device per MDR 2017/745 Annex VIII, it carries CE marking (EU Representative: RWD Medical Devices GmbH, DE) and is registered with China NMPA (Registration No. GD20220123XXXX). Device traceability is maintained via laser-engraved model number and batch identifier on the shank.

Software & Data Management

This is a manually operated, non-electronic surgical instrument; no embedded software, firmware, or digital connectivity is present. Instrument usage records—including sterilization logs, maintenance history, and inventory tracking—are managed externally via hospital or lab LIMS (Laboratory Information Management Systems) or CMMS (Computerized Maintenance Management Systems). Documentation complies with FDA 21 CFR Part 11 requirements when integrated into validated electronic record systems, provided audit trails, electronic signatures, and version-controlled SOPs are applied per institutional GLP/GMP policies.

Applications

• Clinical post-surgical suture removal in outpatient departments, dermatology clinics, and ambulatory surgery centers
• Veterinary wound management across small animal, equine, and laboratory species (e.g., rodent survival surgeries under AAALAC-accredited protocols)
• Academic and industrial biomedical research labs performing longitudinal wound healing studies requiring standardized suture handling
• Medical device training simulators and surgical skills laboratories for competency-based assessment of suture technique
• Quality assurance workflows in suture manufacturing facilities for physical verification of knot integrity and tensile behavior

FAQ

Is this forceps suitable for removing absorbable sutures?
Yes — though primarily optimized for non-absorbables, it may be used for exposed segments of absorbable sutures (e.g., fast-absorbing gut or chromic gut) where mechanical removal is clinically indicated.
What is the recommended sterilization protocol?
Autoclaving at 134 °C for 5 minutes (prevacuum cycle) or 121 °C for 20 minutes (gravity displacement); chemical sterilants (e.g., glutaraldehyde) are not recommended due to potential corrosion risk.
Does RWD provide calibration or certification documentation?
As a passive mechanical instrument, formal calibration is not applicable; however, each batch undergoes dimensional inspection per ISO 9001 and receives a Certificate of Conformance with material test reports and sterilization validation summaries.
Can this model be customized with OEM branding?
Yes — RWD offers private-label manufacturing for healthcare institutions and distributors, including custom laser engraving, packaging, and IFU localization compliant with local regulatory language requirements.