FDA product code PYE: Staple Removal Kit
PYE is the FDA product code for staple removal kit. It is a Class I device, regulated under 21 CFR 878.4760 and reviewed by the General and Plastic Surgery panel. FDA has cleared 1 510(k) submission under PYE. The average 510(k) review took 27 days (median 27).
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.
Classification
| Field | Value |
|---|---|
| Device name | Staple Removal Kit |
| Device class | Class I |
| Regulation | 21 CFR 878.4760 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every PYE clearance
Top PYE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pelco, Inc. | 1 | 1984-11-19 |
Most recent PYE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K844110 | Pelco, Inc. | XTRACETEZE SURGICAL SKIN STAPLE REMOVER 2001 | 1984-11-19 | 27 |
Recalls for PYE devices
openFDA lists no recalls for product code PYE.
Frequently asked questions
What is FDA product code PYE?
PYE is the FDA product code for staple removal kit. It is a Class I device, regulated under 21 CFR 878.4760 and reviewed by the General and Plastic Surgery panel.
What device class is PYE?
Class I, regulation 21 CFR 878.4760. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code PYE?
Across 1 cleared submissions the average was 27 days from receipt to decision (median 27).
Which companies have the most PYE clearances?
Pelco, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PYE
- Run a recall and safety report across every PYE manufacturer
- Watch product code PYE for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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