FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HYDROFLOW SUCTION IRRIGATION SYSTEM
K Number: K833189
·
Decision Nov 28, 1983
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
20
Review Days
70
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Basic Information
- Device Name
- HYDROFLOW SUCTION IRRIGATION SYSTEM
- K Number
- K833189
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Portex, Inc.
- Date Received
- September 19, 1983
- Decision Date
- November 28, 1983
- 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 Portex, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K033080 | PORTEX 24G PEDIATRIC EPIDURAL AND PERIPHERAL BLOCK ANESTHESIA CATHETER | Mar 10, 2004 | Substantially Equivalent |
| K031057 | PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT | Jul 18, 2003 | Substantially Equivalent |
| K023793 | 1ST RESPONSE INTERMEDIATE MANUAL RESUSCITATOR | Feb 11, 2003 | Substantially Equivalent |
| K014115 | 1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX | Feb 27, 2002 | Substantially Equivalent |
| K014073 | HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PROTECTION DEVICE | Feb 13, 2002 | Substantially Equivalent |
| K873992 | LARYNGECTOMY TUBE | Mar 24, 1988 | Substantially Equivalent |
| K874597 | THERMOVENT 600, 1200, T, 02 | Jan 19, 1988 | Substantially Equivalent |
| K862167 | MINI-TRACH KIT | Aug 6, 1986 | Substantially Equivalent |
| K842456 | JET VENTILATION ADAPTOR | Jul 6, 1984 | Substantially Equivalent |
| K833908 | IRRI-CATH | Feb 4, 1984 | Substantially Equivalent |