Probe Sheath for Adms & Capistrano Labs Transrec.
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K896680 FDA 510(k)
- FDA Product Code
- FED 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)
This device is an endoscopic access overtube used in gastroenterology and urology procedures. It is designed to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
The probe sheath is supplied as a non-sterile, reusable device intended for use in clinical settings. It received FDA 510(k) clearance (K896680) on February 14, 1990, and is classified as a Class II medical device under regulation 876.1500 with product code FED.
Frequently asked questions
What is the PROBE SHEATH FOR ADMS & CAPISTRANO LABS TRANSREC used for?
This device is an endoscopic access overtube designed to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals during gastroenterology and urology procedures.
Is the PROBE SHEATH FOR ADMS & CAPISTRANO LABS TRANSREC sterile or non-sterile, and is it intended for single use or reuse?
The probe sheath is supplied as a non-sterile, reusable device intended for use in clinical settings, meaning it must be cleaned and sterilized by the user before each use and can be used multiple times following proper reprocessing.
What regulatory pathway was used for the PROBE SHEATH FOR ADMS & CAPISTRANO LABS TRANSREC, and when was it cleared?
The device received FDA 510(k) clearance under submission K896680 on February 14, 1990, and is classified as a Class II medical device under regulation 876.1500 with product code FED.
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: Probe Sheath for Adms & Capistrano Labs Transrec. (K896680) — Fda 510 ..., PROBE SHEATH FOR ADMS & CAPISTRANO LABS TRANSREC. 510 (k) K896680 - FDA ..., Probe Sheath for Adms Ultrasound Probe - Beudamed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K896680 | Class II | Active |
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Manufacturer
- Manufacturer
- Interson Corp
- FDA Applicant
- Interson Corp.
Sources (1)
- FDA 510(k) K896680 24 fields · synced Oct 6, 2026