FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TUBE, GASTRO-ENTEROSTOMY
K Number: K760810
·
Decision Feb 28, 1977
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
11
Applicant Total
62
Review Days
149
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
- TUBE, GASTRO-ENTEROSTOMY
- K Number
- K760810
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5895
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Sherwood Medical Industries
- Date Received
- October 2, 1976
- Decision Date
- February 28, 1977
- Product Code
- EXD
- 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 |
|---|---|---|---|
| EXD | Irrigator, Ostomy | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EXD), ordered by most recent decision date.
OSTOMY IRRIGATION SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
URINARY DIVERSION EVACUATING CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PALEX IRRIGATION SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BLOXOM IRRIGATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
IRRIGATION SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VISI-FLOW IRRIGATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Sherwood Medical Industries
| K Number | Device Name | ||
|---|---|---|---|
| K801070 | SHERWOOD DISPOSABLE ENDOMETRIAL SAMPLES | Jul 21, 1980 | Substantially Equivalent |
| K801071 | LANCER GLUCOSE RATE REAGENT KIT | May 23, 1980 | Substantially Equivalent |
| K792013 | LANCER L-INA HUMAN REFERENCE SERUM | Nov 13, 1979 | Substantially Equivalent |
| K792014 | LANCER L-INA BUFFER, POLYMER, WASH SOLU | Nov 13, 1979 | Substantially Equivalent |
| K782077 | LANCER ICE CUBE | Apr 3, 1979 | Substantially Equivalent |
| K790523 | ARGYLE ESOPHAGEAL STETHOSCOPE | Mar 27, 1979 | Substantially Equivalent |
| K790196 | MONOJECT ARTERIAL BLOOD SAMPLING DEVICE | Mar 13, 1979 | Substantially Equivalent |
| K790197 | REAGENT KIT, LANCER GLUCOSE | Mar 12, 1979 | Substantially Equivalent |
| K781459 | MONOJECT SCALE MAGNIFIER | Oct 24, 1978 | Substantially Equivalent |
| K781060 | MONOJECT ENDOSSEOUS DENTAL IMPLANT | Aug 14, 1978 | Substantially Equivalent |