FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REPLACEMENT SILICONE GASTROSTOMY TUBE KIT #87600
K Number: K880201
·
Decision Apr 14, 1988
Classifications
1
FEI Numbers
228
Registration Numbers
229
Same Product Code
648
Applicant Total
14
Review Days
90
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- REPLACEMENT SILICONE GASTROSTOMY TUBE KIT #87600
- K Number
- K880201
- 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
- January 15, 1988
- Decision Date
- April 14, 1988
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KNT), ordered by most recent decision date.
XNY Disposable Gastric Calibration Tube
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Flexi-Seal AIR (with ENFit Connector)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
hygh-tec Drainage II
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ZZIREN Orogastric Tube; ZZIREN SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN GBT Orogastric Tube - 40 Fr (ZZ-GBT-40)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Entarik NI Feeding Tube System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CORGRIP* SR NG/NI Tube Retention System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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 |