FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ASI TCU PROSTATIC URETHROPLASTY CATHETER & ACCESS.
K Number: K896713
·
Decision May 24, 1990
Classifications
1
FEI Numbers
67
Registration Numbers
67
Same Product Code
26
Applicant Total
9
Review Days
176
Basic Information
- Device Name
- ASI TCU PROSTATIC URETHROPLASTY CATHETER & ACCESS.
- K Number
- K896713
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5520
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- ADVANCED SURGICAL INTERVENTION, INC.
- Date Received
- November 29, 1989
- Decision Date
- May 24, 1990
- Product Code
- KOE
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KOE | Dilator, Urethral | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by ADVANCED SURGICAL INTERVENTION, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K954215 | MINIGUARD | May 8, 1996 | Substantially Equivalent |
| K926110 | ASI LIGASURE(TM) SUTURE LIGATION INSTRUMENT | Jul 8, 1993 | Substantially Equivalent |
| K930361 | ASI CYSTOLASE LASER CYSTOSCOPE | Apr 29, 1993 | Substantially Equivalent |
| K921990 | ASI UROPLASTY LASER CYSTOSCOPE | Oct 28, 1992 | Substantially Equivalent |
| K902585 | UROPLASTY TCU PROSTATIC URETHROPLASTY CATHETER | Aug 27, 1990 | Substantially Equivalent |
| K901336 | ASI HEMOSTASIS CATHETER | Jun 20, 1990 | Substantially Equivalent |
| K895182 | ASI CYSTOSCOPE SHEATH, GRASPING FORCEPS & FOR.BODY | Oct 24, 1989 | Substantially Equivalent |
| K874530 | URETHRAL DILATOR ENDOSCOPE | Jan 27, 1988 | Substantially Equivalent |