← FDA Medical Device Classifications
Basin For Endoscope Reprocessing
PHT · Class I — Low Risk (general controls) · Gastroenterology, Urology · 21 CFR 876.1500
Classification
- FDA Product Code
PHT- Device class
- Class I — Low Risk (general controls)
- Regulation
- 21 CFR 876.1500
- Review panel
- GU
- Medical specialty
- Gastroenterology, Urology
- Submission type
- 4
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
To allow endoscopes to soak in reprocessing solutions.
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 15
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown