FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DISPOSABLE ASPIRATION IRRIGATION SYSTEM
K Number: K912093
·
Decision Apr 24, 1992
Classifications
1
FEI Numbers
153
Registration Numbers
153
Same Product Code
337
Applicant Total
13
Review Days
346
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Basic Information
- Device Name
- DISPOSABLE ASPIRATION IRRIGATION SYSTEM
- K Number
- K912093
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1720
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Applied Urology, Inc.
- Date Received
- May 14, 1991
- Decision Date
- April 24, 1992
- Product Code
- HET
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HET | Laparoscope, Gynecologic (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by Applied Urology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K921838 | ACUCISE URETERAL CUTTING CATHETER | Feb 26, 1993 | Substantially Equivalent |
| K925282 | UROLOGICAL CATHETER AND ACCESSORIES | Jan 13, 1993 | Substantially Equivalent |
| K920695 | URETERAL STENT | Sep 23, 1992 | Substantially Equivalent |
| K915219 | URETHRAL ELECTRODE SHEATH | Jul 23, 1992 | Substantially Equivalent |
| K920030 | SURESEAL ENDOSCOPIC VALVE | Mar 18, 1992 | Substantially Equivalent |
| K912656 | ENDOSCOPIC ELECTRODE | Sep 16, 1991 | Substantially Equivalent |
| K912903 | PERCUTANEOUS RETRACTOR KIT | Aug 16, 1991 | Substantially Equivalent |
| K905731 | FLEXIBLE ENDOSCOPIC ELECTRODE | Jan 31, 1991 | Substantially Equivalent |
| K903994 | URETEROPYELOGRAM CATH FOR RETROGRADE DYE INJECTION | Oct 19, 1990 | Substantially Equivalent |
| K901214 | RIGID URETEROSCOPE | Jun 1, 1990 | Substantially Equivalent |