Dynamic DIAGNOSTICS, INC PEN21
Dynamic DIAGNOSTICS, INC PEN21 is a Class II device made by Bioprotech Inc., cleared under FDA 510(k) K092732 on 25 Nov 2009 and listed in FDA GUDID since 12 Mar 2025 (UDI-DI 00851255007104), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00851255007104 | Date12 Mar 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK092732 | Date25 Nov 2009 | StatusActive |
Official records
- AccessGUDID record 00851255007104
- FDA 510(k) database K092732
Across registries
- FDA 510(k) K092732 decided 25 Nov 2009 Active
- FDA GUDID UDI-DI 00851255007104 listed 12 Mar 2025 Listed
Timeline
- Cleared FDA 510(k) K092732
- Listed FDA GUDID 00851255007104
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Dynamic DIAGNOSTICS, INC
- Generic name
- Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
- Model / reference
- PEN21
- Primary DI / UDI-DI
- 00851255007104
- 510(k) Number
- FDA product code
- GEI
- GMDN term
- Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution
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