Stylet, Surgical, General & Plastic Surgery
The Stylet, Surgical, General and Plastic Surgery (product code GAH) is a slender, rigid or semi-rigid wire or rod inserted into a catheter or needle to maintain its shape or guide its placement during surgical procedures in general and plastic surgery. It is classified as FDA Class 1, the lowest risk level, requiring only general controls and no premarket notification. The device is regulated under 21 CFR 878.4800 in the General, Plastic Surgery specialty (SU). No special flags apply to this device.
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Basic Information
- Product Code
- GAH
- Device Class
- FDA class 1
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K110355 | VENX REVOLUTION | Apr 22, 2011 | Substantially Equivalent | Venx, LLC |
| K000932 | ARACHNOPHLEBECTOMY NEEDLE | May 17, 2000 | Substantially Equivalent | Advanced Medical Products, Inc. |
| K970306 | MARKMAN TEMPLATE SYSTEM | Nov 20, 1997 | Substantially Equivalent | Barry Markman, M.D. |
| K972918 | RAPID FIRE HAIR IMPLANTER CAROUSEL | Oct 27, 1997 | Substantially Equivalent | Apex Medical Products, LLC |
| K972521 | NAVIGATOR (STYLET) 2006 | Oct 01, 1997 | Substantially Equivalent | Sil-Med Corp. |
| K952737 | CALVITRON HAIR TRANSPLANT SYSTEM | Oct 03, 1995 | Substantially Equivalent | Medicamat S.A. |
| K770970 | HAIR TRANSPLANT PUNCH, MULTIPLH | Oct 27, 1977 | Substantially Equivalent | Padgett Instruments, Inc. |
FEI Numbers
This FDA classification entry is associated with 97 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 97 registration numbers. Click on an entry to view related FDA registrations.