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Dissolvable Gel For Preventing Ureteral Stone Migration

Page Type
Product Code
Definition
For use in the ureter to prevent the migration of urinary calculi and their fragments during intracorporeal lithotripsy procedures.
Physical State
The device is an injectable gel that is capable of being dissolved using endoscopic irrigation.
Technical Method
The gel temporarily obstructs the ureter to limit the migration of urinary calculi and their fragments during intracorporeal lithotripsy procedures. After the lithotripsy procedure, the gel is dissolved using irrigation.
Target Area
The target area is the ureter.
Regulation Medical Specialty
Gastroenterology and Urology
Review Panel
Gastroenterology and Urology
Submission Type
510(K) Exempt
Device Classification
Class 2
Regulation Number
876.4680
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 876.4680 Ureteral stone dislodger

§ 876.4680 Ureteral stone dislodger.

(a) Identification. A ureteral stone dislodger is a device that consists of a bougie or a catheter with an expandable wire basket near the tip, a special flexible tip, or other special construction. It is inserted through a cystoscope and used to entrap and remove stones from the ureter. This generic type of device includes the metal basket and the flexible ureteral stone dislodger.

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

[48 FR 53023, Nov. 23, 1983, as amended at 63 FR 59228, Nov. 3, 1998]

Dissolvable Gel For Preventing Ureteral Stone Migration

Page Type
Product Code
Definition
For use in the ureter to prevent the migration of urinary calculi and their fragments during intracorporeal lithotripsy procedures.
Physical State
The device is an injectable gel that is capable of being dissolved using endoscopic irrigation.
Technical Method
The gel temporarily obstructs the ureter to limit the migration of urinary calculi and their fragments during intracorporeal lithotripsy procedures. After the lithotripsy procedure, the gel is dissolved using irrigation.
Target Area
The target area is the ureter.
Regulation Medical Specialty
Gastroenterology and Urology
Review Panel
Gastroenterology and Urology
Submission Type
510(K) Exempt
Device Classification
Class 2
Regulation Number
876.4680
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 876.4680 Ureteral stone dislodger

§ 876.4680 Ureteral stone dislodger.

(a) Identification. A ureteral stone dislodger is a device that consists of a bougie or a catheter with an expandable wire basket near the tip, a special flexible tip, or other special construction. It is inserted through a cystoscope and used to entrap and remove stones from the ureter. This generic type of device includes the metal basket and the flexible ureteral stone dislodger.

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

[48 FR 53023, Nov. 23, 1983, as amended at 63 FR 59228, Nov. 3, 1998]