Accessories, Photographic, For Endoscope (Exclude Light Sources)
Photographic Accessories for Endoscope (excluding light sources) are ancillary components used to capture still or video images during endoscopic examination of the gastrointestinal and urological systems. These accessories are FDA Class 1 devices, representing the lowest risk tier and subject only to general controls. The product code is FEM, regulated under 21 CFR 876.1500, within the Gastroenterology, Urology specialty.
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Basic Information
- Product Code
- FEM
- Device Class
- FDA class 1
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K940152 | CAMERA COVER WITH TEAR TIP | Oct 28, 1994 | Substantially Equivalent | Hydro-Med Products, Inc. |
| K812542 | POLAROID INSTANT ENDOCAMERA | Oct 19, 1981 | Substantially Equivalent | Polaroid Corp. |
| K812201 | PHOTOGRAPHIC EQUIPMENT | Oct 19, 1981 | Substantially Equivalent | Reznik Instruments |
| K792512 | POLAROID LAND CAMERA FOR ENDOSCOPY | Dec 20, 1979 | Substantially Equivalent | Polaroid Corp. |
FEI Numbers
This FDA classification entry is associated with 63 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 63 registration numbers. Click on an entry to view related FDA registrations.