FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CONWAY STUART MODEL 100 IRRIGATION PUMP & ACCESSORIES
K Number: K990724
·
Decision Aug 13, 1999
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
10
Review Days
161
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Basic Information
- Device Name
- CONWAY STUART MODEL 100 IRRIGATION PUMP & ACCESSORIES
- K Number
- K990724
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Conway Stuart Medical, Inc.
- Date Received
- March 5, 1999
- Decision Date
- August 13, 1999
- Product Code
- GCJ
- Advisory Committee
- Gastroenterology, Urology
- 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Conway Stuart Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K000245 | CSM STRETTA SYSTEM | Apr 18, 2000 | Substantially Equivalent |
| K000170 | SECCA TUBULAR ELECTRODE DEVICE, MODEL A4000 | Feb 14, 2000 | Substantially Equivalent |
| K992542 | TUBULAR ELECTRODE DEVICE | Oct 27, 1999 | Substantially Equivalent |
| K991529 | CSM STRETTA CONTROL MODULE ELECTROSURGICAL GENERATOR, MODEL S400 | Sep 14, 1999 | Substantially Equivalent |
| K991291 | STRETTA INFLATABLE BASKET CATHETER ELECTRODE WITH ASPIRATION | Jul 14, 1999 | Substantially Equivalent |
| K983986 | CONWAY STUART MEDICAL MODEL C4 ELECTROSURGICAL GENERATOR | Mar 23, 1999 | Substantially Equivalent |
| K983116 | ELECTROSURGICAL INFLATABLE BASKET ELECTRODES | Dec 3, 1998 | Substantially Equivalent |
| K983415 | DELIVERY SHEATH | Dec 1, 1998 | Substantially Equivalent |
| K981589 | ELECTROSURGICAL BASKET ELECTRODES ELECTROSURGICAL BASKET ELECTRODES | Jul 30, 1998 | Substantially Equivalent |