FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ASI UROPLASTY LASER CYSTOSCOPE
K Number: K921990
·
Decision Oct 28, 1992
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
9
Review Days
183
Basic Information
- Device Name
- ASI UROPLASTY LASER CYSTOSCOPE
- K Number
- K921990
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- ADVANCED SURGICAL INTERVENTION, INC.
- Date Received
- April 28, 1992
- Decision Date
- October 28, 1992
- Product Code
- GEX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | FDA class 2 | General, Plastic Surgery |
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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 |
| K902585 | UROPLASTY TCU PROSTATIC URETHROPLASTY CATHETER | Aug 27, 1990 | Substantially Equivalent |
| K901336 | ASI HEMOSTASIS CATHETER | Jun 20, 1990 | Substantially Equivalent |
| K896713 | ASI TCU PROSTATIC URETHROPLASTY CATHETER & ACCESS. | May 24, 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 |