N-Do Endoinjector Needle, Model PH00961109 and PH00961110
510(k) K043383
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK043383 | Date27 Oct 2005 | 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- Withdrawn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
- FBK
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The N-DO Endoinjector Needle is an endoscopic injection needle designed for precise delivery of therapeutic agents during urological and gastroenterological procedures. It facilitates targeted administration into the urethra, prostate, and vesical cavities, enabling minimally invasive interventions for therapeutic purposes.
This device is supplied sterile and intended for single-use, adhering to FDA 510(k) clearance (K043383) under Class II regulatory classification. It is used in conjunction with endoscopic systems and must be handled in accordance with sterile medical device protocols. Models PH00961109 and PH00961110 are explicitly identified for regulatory and procedural compliance.
Other devices from Physion, Inc.
Questions
AI-generated answers, 19 Sep 2026
What medical specialties are the N-DO Endoinjector Needle primarily used in, and how does this relate to its design purpose?
The N-DO Endoinjector Needle is designed for use in gastroenterology and urology, as indicated by its FDA 510(k) clearance under the GU (Gastroenterology-Urology) advisory committee. Its purpose is to deliver therapeutic agents precisely during endoscopic procedures, targeting areas like the urethra, prostate, and vesical cavities. This specialization ensures compatibility with minimally invasive techniques used in these fields.
Are the N-DO Endoinjector Needle models PH00961109 and PH00961110 reusable, and what does this mean for clinical workflows?
No, the N-DO Endoinjector Needle is intended for single-use only, as explicitly stated in its description. This means each needle must be discarded after a single procedure to maintain sterility and reduce infection risks. Clinicians should follow sterile medical device protocols, ensuring proper handling and disposal to comply with regulatory and safety standards.
How is the sterility of the N-DO Endoinjector Needle ensured, and what does this imply for storage and handling?
The device is supplied sterile, meaning it is packaged and sealed to prevent contamination before use. To preserve sterility, it must be stored in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Once opened, the needle should be used immediately and discarded, as reuse is not permitted.
What regulatory pathway was followed for the FDA clearance of the N-DO Endoinjector Needle, and what does this classification mean for its use?
The N-DO Endoinjector Needle received FDA 510(k) clearance (K043383) under the Class II regulatory classification, determined through a substantially equivalent comparison to a predicate device. This classification means the device undergoes stricter manufacturing controls and post-market surveillance to ensure safety and effectiveness, while still allowing for innovation in design and functionality within the approved indications.