Obturator, For Endoscope
The Obturator for Endoscope (product code FEC) is a blunt-tipped plug inserted into the working channel or sheath of an endoscope to facilitate safe introduction into the body without trauma to mucosal surfaces. It is an FDA Class 2 device (moderate risk), requiring 510(k) premarket clearance. It is regulated under 21 CFR 876.1500 in the Gastroenterology and Urology specialty. No special flags apply.
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Basic Information
- Product Code
- FEC
- Device Class
- FDA class 2
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
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 |
|---|---|---|---|---|
| K001328 | INTRODUCER SHEATH | Jul 17, 2000 | Substantially Equivalent | Novasys Medical, Inc. |
| K760183 | OBTURATOR, DEFLECTING | Dec 02, 1976 | Substantially Equivalent | V. Mueller O.V. Baxter Healthcare Corp. |
| K760172 | OBTURATOR, VISUAL | Dec 02, 1976 | Substantially Equivalent | V. Mueller O.V. Baxter Healthcare Corp. |
FEI Numbers
This FDA classification entry is associated with 14 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 14 registration numbers. Click on an entry to view related FDA registrations.