Last synced on 27 January 2023 at 11:04 pm

Penile Implant Surgical Accessories

Page Type
Product Code
Definition
Penile implant surgical accessories are manual devices designed to be used for surgical procedures associated with the implantation of a penile inflatable implant or penile rigidity implant. This generic type of device includes the cylinder sizer, cylinder insertion tool and needle, device placement tool, connector assembly tool, incision closing tool, corporeal dilator, tubing passer, measurement tool or tape, tubing plug, blunt needle, and hemostat shod tubing.
Physical State
Cylinder sizer, cylinder insertion tool and needle, device placement tool, connector assembly tool, incision closing tool, corporeal dilator, tubing passer, measurement tool or tape, tubing plug, blunt needle, and hemostat shod tubing
Technical Method
These instruments are used to aid in implantation of a penile inflatable implant or a penile rigidity implant.
Target Area
Penis
Regulation Medical Specialty
Gastroenterology and Urology
Review Panel
Gastroenterology and Urology
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
876.3500
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 876.3500 Penile implant surgical accessories

§ 876.3500 Penile implant surgical accessories.

(a) Identification. Penile implant surgical accessories are manual devices designed to be used for surgical procedures associated with the implantation of a penile inflatable implant or penile rigidity implant. This generic type of device includes the cylinder sizer, cylinder insertion tool and needle, device placement tool, connector assembly tool, incision closing tool, corporeal dilator, tubing passer, measurement tool or tape, tubing plug, blunt needle, and hemostat shod tubing.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

[84 FR 14869, Apr. 12, 2019]

Penile Implant Surgical Accessories

Page Type
Product Code
Definition
Penile implant surgical accessories are manual devices designed to be used for surgical procedures associated with the implantation of a penile inflatable implant or penile rigidity implant. This generic type of device includes the cylinder sizer, cylinder insertion tool and needle, device placement tool, connector assembly tool, incision closing tool, corporeal dilator, tubing passer, measurement tool or tape, tubing plug, blunt needle, and hemostat shod tubing.
Physical State
Cylinder sizer, cylinder insertion tool and needle, device placement tool, connector assembly tool, incision closing tool, corporeal dilator, tubing passer, measurement tool or tape, tubing plug, blunt needle, and hemostat shod tubing
Technical Method
These instruments are used to aid in implantation of a penile inflatable implant or a penile rigidity implant.
Target Area
Penis
Regulation Medical Specialty
Gastroenterology and Urology
Review Panel
Gastroenterology and Urology
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
876.3500
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 876.3500 Penile implant surgical accessories

§ 876.3500 Penile implant surgical accessories.

(a) Identification. Penile implant surgical accessories are manual devices designed to be used for surgical procedures associated with the implantation of a penile inflatable implant or penile rigidity implant. This generic type of device includes the cylinder sizer, cylinder insertion tool and needle, device placement tool, connector assembly tool, incision closing tool, corporeal dilator, tubing passer, measurement tool or tape, tubing plug, blunt needle, and hemostat shod tubing.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

[84 FR 14869, Apr. 12, 2019]