FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PAPILLOTOME
K Number: K851652
·
Decision Jun 24, 1985
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
187
Applicant Total
18
Review Days
63
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
- PAPILLOTOME
- K Number
- K851652
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4300
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Microvasive
- Date Received
- April 22, 1985
- Decision Date
- June 24, 1985
- 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.
Sphincterotome
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Vanquish Water Vapor Ablation Device
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SureTome SW Sphincterotome with DomeTip
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Microvasive
| K Number | Device Name | ||
|---|---|---|---|
| K872771 | LOW PROFILE GASTROSTOMY | Oct 9, 1987 | Substantially Equivalent |
| K870705 | THERMAL COAGULATOR | Apr 17, 1987 | Substantially Equivalent |
| K861309 | JEJUNAL FEEDING TUBE | Dec 16, 1986 | Substantially Equivalent |
| K861323 | REPLACEMENT GASTROSTOMY TUBE | Dec 16, 1986 | Substantially Equivalent |
| K860589 | INFLATOR/DEFLATOR PISTON SYRINGE | Apr 7, 1986 | Substantially Equivalent |
| K860366 | CHALLENGER HOT BIOPSY FORCEPS | Apr 7, 1986 | Substantially Equivalent |
| K854238 | NEEDLE W/STYLET FOR IMPLANTATION | Nov 13, 1985 | Substantially Equivalent |
| K854063 | MICROVASIVE SILICONE SPRAY | Oct 25, 1985 | Substantially Equivalent |
| K850393 | FLEXIBLE FIBEROPTIC ENDOSCOPE | Jun 4, 1985 | Substantially Equivalent |
| K844769 | RIGID FIBEROPITC ENDOSCOPE | Jan 15, 1985 | Substantially Equivalent |