Product Classification Database
Device | gynecological laparoscopic kit |
Regulation Description | Gynecologic laparoscope and accessories. |
Definition |
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.
Fda.
Gov/cdrh/ode/convkit.
Html.
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.
|
Physical State |
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. 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. |
Technical Method |
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. 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. |
Target Area |
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. 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. |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
Review Panel |
Obstetrics/Gynecology
|
Product Code | OHD |
Submission Type |
Enforcement Discretion
|
Regulation Number |
884.1720
|
Device Class |
2
|
GMP Exempt? |
No
|
Third Party Review |
Not Third Party Eligible |
|
|