Excisor Bioptome, Model 01-0004
510(k) K032847
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK032847 | Date26 Sep 2003 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KNW
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1075
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Excisor Bioptome, Model 01-0004, is a multiple-action biopsy system designed for obtaining soft tissue biopsies. It is classified under product code KNW and is intended for precise tissue excision in clinical settings, ensuring accurate sample acquisition for diagnostic purposes.
This device is supplied sterile and intended for single-use. It is regulated under FDA 510(k) clearance (K032847) and falls under the Gastroenterology and Urology advisory committees. The system is intended for use in controlled medical environments, adhering to standard sterility and safety protocols for biopsy procedures.
Other devices from Acueity, Inc.
Questions
AI-generated answers, 19 Sep 2026
What clinical specialties is the Excisor Bioptome primarily used in, and why is it designed for those areas?
The Excisor Bioptome, Model 01-0004, is primarily associated with gastroenterology and urology due to its classification under product code KNW and its regulatory review by the Gastroenterology and Urology advisory committees. It is designed for these specialties because it specializes in precise soft tissue biopsy excision, which is critical for obtaining accurate diagnostic samples in procedures involving organs and tissues commonly accessed in these fields, such as the gastrointestinal tract and urinary system.
Is the Excisor Bioptome reusable or single-use, and what does that mean for clinical workflows?
The Excisor Bioptome is intended for single-use only, meaning each device is designed to be used once and then discarded. This ensures sterility and reduces the risk of cross-contamination between patients, which is particularly important for biopsy procedures where tissue integrity and safety are paramount. Clinicians must follow standard single-use protocols, including proper disposal after use, to maintain workflow efficiency and compliance with infection control standards.
How is the Excisor Bioptome supplied, and what does 'sterile' mean in this context?
The Excisor Bioptome is supplied sterile, meaning it is packaged and processed to eliminate or reduce microorganisms to a level that ensures safe use without causing infection. This is critical for biopsy procedures, where even trace contamination could compromise diagnostic accuracy or patient safety. Clinicians should verify the sterility seal and expiration date before use, adhering to manufacturer guidelines for opening and handling to preserve sterility.
What does the FDA 510(k) clearance (K032847) indicate about the Excisor Bioptome’s regulatory status, and how does it affect its use?
The FDA 510(k) clearance (K032847) confirms that the Excisor Bioptome has been determined to be substantially equivalent to a legally marketed predicate device, meaning it meets the same performance standards and safety requirements. This clearance does not imply an indication for use but rather validates that the device adheres to regulatory expectations for biopsy systems in controlled medical environments. Clinicians can rely on this clearance as assurance of the device’s compliance with FDA standards for precision and safety in soft tissue excision.