Franzen Needle Guide
510(k) K830235
Franzen Needle Guide is a medical device (FDA Class I; FDA product code GDM, Needle, Aspiration And Injection, Reusable) made by Precision Dynamics Corp., cleared under FDA 510(k) K830235 on 23 Feb 1983, 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 | FDA 510(k)SESE | NumberK830235 | Date23 Feb 1983 | StatusActive |
Official records
- FDA 510(k) database K830235
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GDM
- Device class
- Class I
- Regulation
- 21 CFR Part 878.4800
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
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- WILLIAMS-FRITTS PLEURAL BIOPSY NEEDLE by E.G. Dick & Assoc.