Endoscope Introducer Kit
The Endoscope Introducer Kit (product code NWU) is a convenience kit used to facilitate the introduction of an endoscope during endoscopic procedures, regulated under 21 CFR 876.1500 within the Gastroenterology and Urology specialty. As a Class 2 convenience kit under the May 1997 Convenience Kits Interim Regulatory Guidance, it is under enforcement discretion and does not require a 510(k) to market. The device carries no implant or life-sustaining flags.
Basic Information
- Product Code
- NWU
- Device Class
- FDA class 2
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 7
Device Characteristics
Definition
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K933268 | CANDELA GUIDEWIRE | Feb 10, 1994 | Substantially Equivalent | CANDELA LASER CORP. |
| K874045 | PHARMASEAL ENDOSCOPY PREP KIT UPPER AND LOWER | Dec 03, 1987 | Substantially Equivalent | AMERICAN PHARMASEAL DIV. AHSC |
| K813332 | BRISTOL BALLON INTRODUCER, MANDRIL SET | Dec 14, 1981 | Substantially Equivalent | INMED CORP. |
FEI Numbers
This FDA classification entry is associated with 36 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 36 registration numbers. Click on an entry to view related FDA registrations.