FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
M.R. ASSOC. TRUE-FEEL HANDLE
K Number: K800975
·
Decision May 8, 1980
Classifications
1
FEI Numbers
118
Registration Numbers
118
Same Product Code
180
Applicant Total
15
Review Days
15
Basic Information
- Device Name
- M.R. ASSOC. TRUE-FEEL HANDLE
- K Number
- K800975
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4300
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- MR ASSOCIATES, INC.
- Date Received
- April 23, 1980
- Decision Date
- May 8, 1980
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KNS), ordered by most recent decision date.
Rezum System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SpydrBlade Flex Instrument (PRD-RG1-001)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SB Knife Jr2 (MD-47702 and MD-47702L)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Disposable Sphincterotome
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Aqua Medical RF Vapor Ablation System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by MR ASSOCIATES, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K800970 | M.R. ASSOC. BASKET RETRIEVERS | May 8, 1980 | Substantially Equivalent |
| K800972 | M.R. ASSOC. TRIPOD GRASPING FORCEPS | May 8, 1980 | Substantially Equivalent |
| K800962 | M.R. ASSOC. WASHING TUBE/MEASURING TUBE | May 8, 1980 | Substantially Equivalent |
| K800971 | M.R. ASSOC. MAGNETIC EXTRACTOR | May 8, 1980 | Substantially Equivalent |
| K800976 | M.R. ASSOC. W TYPE GRASPING FORCEPS | May 8, 1980 | Substantially Equivalent |
| K800966 | M.R. ASSOC. CYTOLOGY BRUSHES | May 8, 1980 | Substantially Equivalent |
| K800969 | M.R. ASSOC. CANNULAS | May 8, 1980 | Substantially Equivalent |
| K800965 | M.R. ASSOC. SNARES; CRESCENT SNARE WIRE | May 8, 1980 | Substantially Equivalent |
| K800963 | BIOPSY FORCEPS W/NEEDLE M.R. ASSOC. | May 8, 1980 | Substantially Equivalent |
| K800967 | M.R. ASSOC. ALLIGATOR GRASPONG FORCEPS | May 8, 1980 | Substantially Equivalent |