Advanced Surgical Intervention, Inc.
United StatesFDA applicant, unverified
- Devices
- 9
What Advanced Surgical Intervention, Inc. makes
Advanced Surgical Intervention, Inc. manufactures urological and surgical devices, including hemostasis catheters for controlled bleeding, urethral dilators for endoscopic procedures, and laser cystoscopes for tissue treatment. Their portfolio also includes urethroplasty catheters for prostatic urethral reconstruction, cystoscope sheaths with grasping forceps, and suture ligation instruments for tissue approximation. Additional products cover uropathy-specific tools like the MINIGUARD and specialized sheaths for cystoscopic access.
The company’s devices are classified under FDA categories Class I and Class II, with regulatory submissions recorded via the 510(k) pathway. These products are listed in the FDA’s 510(k) database, reflecting their authorised status under US medical device regulations. The manufacturer operates from the United States.
Catalogue
Asi Hemostasis Catheter Ref K901336
Regimes: 510(k) Registry: 510(k)Urethral Dilator Endoscope Ref K874530
Regimes: 510(k) Registry: 510(k)Asi Uroplasty Laser Cystoscope Ref K921990
Regimes: 510(k) Registry: 510(k)Asi Cystolase Laser Cystoscope Ref K930361
Regimes: 510(k) Registry: 510(k)Miniguard Ref K954215
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Uroplasty Tcu Prostatic Urethroplasty Catheter Ref K902585
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Asi Ligasure(Tm) Suture Ligation Instrument Ref K926110
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Advanced Surgical Intervention, Inc. have in the registry?
The registry currently lists 9 devices for Advanced Surgical Intervention, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Advanced Surgical Intervention, Inc.'s devices?
Among its 9 most recently registered devices, Advanced Surgical Intervention, Inc. has devices listed in FDA 510(k) (9 devices).
What risk classes do Advanced Surgical Intervention, Inc.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Advanced Surgical Intervention, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Advanced Surgical Intervention, Inc. in the registry?
The most recently registered devices listed for Advanced Surgical Intervention, Inc. include ASI HEMOSTASIS CATHETER, URETHRAL DILATOR ENDOSCOPE, ASI UROPLASTY LASER CYSTOSCOPE and ASI CYSTOLASE LASER CYSTOSCOPE.