JYS
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Perforator, Ear-Lobe
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4420
- Medical specialty
- Ear, Nose, Throat
- Adverse events (MAUDE)
- 2002: 28 · 2003: 20 · 2004: 16 · 2005: 20 · 2006: 9 · 2007: 5
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| STUDEX EAR PIERCING GUNS (K860622) | Onyx Industries, Inc. | 1986-10-17 |
| J.K. TEMPLETON EAR PIERCING GUNS/INSTRUMENTS/STUDS (K860678) | Jay Kenny Templeton | 1986-08-29 |
| EAR PIERCING DEVICE (K772171) | Robert C. Cameron | 1978-01-03 |
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Every clearance here is in the API, with alerts when new ones post.