FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POLYPECTOMY SNARE
K Number: K810336
·
Decision Mar 20, 1981
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
187
Applicant Total
36
Review Days
39
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Basic Information
- Device Name
- POLYPECTOMY SNARE
- K Number
- K810336
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4300
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Medi-Tech, Inc.
- Date Received
- February 9, 1981
- Decision Date
- March 20, 1981
- Product Code
- KNS
- 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 |
|---|---|---|---|
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Medi-Tech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K954457 | MEDI-TECH EDDY INTRAVASCULAR INFUSION CATHETER | May 15, 1996 | Substantially Equivalent |
| K952345 | MEDI-TECH PLATFORM GUIDE CATHETER | Aug 17, 1995 | Substantially Equivalent |
| K952056 | IMMUNOASSAY DRUGS OF ABUSE CONTROLS | Jun 1, 1995 | Substantially Equivalent |
| K945289 | DOA - IMMUNOASSAY CUT-OFF CALIBRATOR | Dec 13, 1994 | Substantially Equivalent |
| K942551 | THERAPEUTIC DRUG MONITORING CONTROL, ASSAYED | Oct 6, 1994 | Substantially Equivalent |
| K943290 | BILIRUBIN PLUS/PEDIATRIC CONTROLS | Sep 14, 1994 | Substantially Equivalent |
| K922990 | HEMODIALYSIS BATH | Sep 12, 1994 | Substantially Equivalent |
| K942552 | THERAPEUTIC DRUG MONITORING CONTROL, UNASSAYED | Sep 9, 1994 | Substantially Equivalent |
| K904073 | COAGULATION REFERENCE PLASMA, ABNORMAL | Oct 22, 1990 | Substantially Equivalent |
| K895819 | MODIFIED LABELING TO THE SPAND-GEL GRANULATED GEL | Nov 2, 1989 | Substantially Equivalent for Some Indications |