FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLOW THRU 16,18,20,22 FR REPLACE. GASTRO TUBE KIT
K Number: K885339
·
Decision Mar 1, 1989
Classifications
1
FEI Numbers
228
Registration Numbers
229
Same Product Code
648
Applicant Total
14
Review Days
63
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Basic Information
- Device Name
- FLOW THRU 16,18,20,22 FR REPLACE. GASTRO TUBE KIT
- K Number
- K885339
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Superior Healthcare Group, Inc.
- Date Received
- December 28, 1988
- Decision Date
- March 1, 1989
- Product Code
- KNT
- 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 |
|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Superior Healthcare Group, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K925530 | INSTRUMENT WARMER | Jun 18, 1993 | Substantially Equivalent |
| K924764 | OVERTUBE FOR ENDSCOPIC LIGATOR | Mar 15, 1993 | Substantially Equivalent |
| K905755 | NON-STERILE PATIENT EXAMINATION GLOVES | Mar 8, 1991 | Substantially Equivalent |
| K903347 | SODIUM CHLORIDE SOLUTION | Dec 13, 1990 | Substantially Equivalent |
| K904216 | STERILE WATER SOLUTION CATALOG # 10000 | Nov 16, 1990 | Substantially Equivalent |
| K903340 | STERILE URETHRAL CATHETER PROCEDURE KITS | Oct 4, 1990 | Unknown |
| K896321 | NO. 34100 - 8 FR & NO. 34400 - 14 FR CLOSED TRACH. | Nov 13, 1989 | Substantially Equivalent |
| K894676 | STERILE LATEX EXAM GLOVES | Aug 17, 1989 | Substantially Equivalent |
| K891445 | LATEX EXAMINATION GLOVES | Aug 9, 1989 | Substantially Equivalent |
| K892426 | NO. 86500 - ENDOSCOPIC JET WASHER | Jun 22, 1989 | Substantially Equivalent |