Identifiers
- 510(k) Number
- K241739 FDA 510(k)
- FDA Product Code
- GCJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Endoscopic Applicator, 41 cm, is a medical device classified under 21 CFR 876.1500 as an endoscope accessory. It is designed for endoscopic procedures to deliver hemostatic agents to bleeding sites within the body via a 5 mm or larger trocar, aiding in surgical hemostasis during gastrointestinal or urological interventions.
This device is supplied sterile for single-use and is intended for use in controlled clinical settings such as operating rooms or endoscopy suites. It is regulated under FDA 510(k) clearance (K241739) as a Class II medical device, adhering to strict manufacturing and performance standards. The 41 cm length ensures compatibility with standard endoscopic instruments, and its design complies with regulatory requirements for endoscopic accessories in gastroenterology and urology.
Frequently asked questions
What types of medical procedures is this endoscopic applicator designed to assist with, and how does its length benefit the user?
This applicator is specifically designed for endoscopic procedures in gastroenterology and urology, where it delivers hemostatic agents to control bleeding during interventions. The 41 cm length ensures compatibility with standard endoscopic instruments, allowing for precise delivery through trocars sized 5 mm or larger, which is critical for accessing deeper or more confined bleeding sites in the gastrointestinal or urological tracts.
Is this device reusable, or is it intended for single-use only? How does sterility factor into its use?
The Endoscopic Applicator is sterile and intended for single-use only, as explicitly stated in its description. This design minimizes infection risk in controlled clinical settings like operating rooms or endoscopy suites, where sterility is paramount for patient safety during surgical or diagnostic procedures.
How is this device regulated, and what does the FDA’s clearance classification mean for its use?
This device is regulated under FDA 510(k) clearance (K241739) as a Class II medical device, classified under 21 CFR 876.1500 as an endoscope accessory. The clearance indicates it has been deemed substantially equivalent to a legally marketed predicate device, meeting strict manufacturing and performance standards for endoscopic hemostasis applications in gastroenterology and urology.
What should clinicians consider when storing this applicator before use, given its single-use nature?
Since the applicator is sterile and single-use, clinicians should store it in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Proper storage ensures sterility is maintained until immediate preoperative or procedural use, as reusing or repackaging it would compromise its sterile integrity.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Endoscopic Applicator, 41 cm (K172672) — FDA 510(k) | Innolitics, Endoscopic Applicator, 41 cm (K241739) — FDA 510(k) | Innolitics, K241739 - Endoscopic Applicator | FDA 510(k) | Micromedics, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K241739 | Class II | Active |
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Manufacturer
- Manufacturer
- Micromedics, Inc.
Sources (1)
- FDA 510(k) K241739 24 fields · synced Sep 19, 2026