FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
M.R. ASSOC. SNARES; CRESCENT SNARE WIRE
K Number: K800965
·
Decision May 8, 1980
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
187
Applicant Total
15
Review Days
15
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Basic Information
- Device Name
- M.R. ASSOC. SNARES; CRESCENT SNARE WIRE
- K Number
- K800965
- 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.
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Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)
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Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)
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Other Clearances by Mr Associates, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K800968 | M.R. ASSOC. RAT TOOTH GRASP FORCEPS | May 8, 1980 | Substantially Equivalent |
| K800967 | M.R. ASSOC. ALLIGATOR GRASPONG FORCEPS | May 8, 1980 | Substantially Equivalent |
| K800963 | BIOPSY FORCEPS W/NEEDLE M.R. ASSOC. | 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 |
| K800974 | M.R. ASSOC. POWER CORD | May 8, 1980 | Substantially Equivalent |
| K800973 | M.R. ASSOC. HOT BIOPSY FORCEPS | May 8, 1980 | Substantially Equivalent |
| K800975 | M.R. ASSOC. TRUE-FEEL HANDLE | May 8, 1980 | Substantially Equivalent |
| K800964 | M.R. ASSOC. BALL TYPE COAGULATOR | May 8, 1980 | Substantially Equivalent |
| K800970 | M.R. ASSOC. BASKET RETRIEVERS | May 8, 1980 | Substantially Equivalent |