PYEClass I
Staple Removal Kit
21 CFR 878.4760 / General, Plastic Surgery
PYE is the FDA product code for Staple Removal Kit, a class I device type, regulated under 21 CFR 878.4760. 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 one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- PYE
- Device name
- Staple Removal Kit
- 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 878.4760
- Device class
- Class I
- Review panel
- General, Plastic Surgery
- Submission type
- FDA code 7
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code PYE
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1984 | 1 |
Applicants with the most clearances
Product code PYE| Applicant | Clearances |
|---|---|
| Pelco, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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