Non-Balloon Replacement Gastrostomy System
PSF is the FDA product code for Non-Balloon Replacement Gastrostomy System, a class II device type, regulated under 21 CFR 876.5980. FDA's definition for this code reads: "This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above...". As of , FDA records hold no 510(k) clearances under this code and no recalls.
Classification record
- Product code
- PSF
- Device name
- Non-Balloon Replacement Gastrostomy System
- FDA definition
- This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
- Regulation
- 21 CFR 876.5980
- Device class
- Class II
- Review panel
- Gastroenterology, Urology
- Submission type
- FDA code 7
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 0
- Ingested recalls
- 0
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code PSF.
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