FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LINDEN STONE EXTRACTION BALLOON
K Number: K872509
·
Decision Sep 22, 1987
Classifications
1
FEI Numbers
137
Registration Numbers
137
Same Product Code
464
Applicant Total
19
Review Days
90
Basic Information
- Device Name
- LINDEN STONE EXTRACTION BALLOON
- K Number
- K872509
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5010
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- HOBBS MEDICAL, INC.
- Date Received
- June 24, 1987
- Decision Date
- September 22, 1987
- Product Code
- FGE
- 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 |
|---|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | FDA class 2 | Gastroenterology, Urology |
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| K Number | Device Name | ||
|---|---|---|---|
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| K030765 | HOBBS MISTIFIER SPRAY CATHETER | Jun 9, 2003 | Substantially Equivalent |
| K933354 | HOBBS MEDICAL CLEANING BRUSH | Oct 28, 1993 | Substantially Equivalent |
| K922396 | FUJINON FORCEPS -- MODIFICATION | Dec 10, 1992 | Substantially Equivalent |
| K921026 | PRESSURE GAUGE | Apr 24, 1992 | Substantially Equivalent |
| K914358 | ENCAPSULATED GUIDEWIRE WITH FLEXIBLE TIP | Nov 19, 1991 | Substantially Equivalent |
| K893729 | HOBBS MEDICAL MICROBIOLOGY BRUSH | Aug 28, 1989 | Substantially Equivalent |
| K860593 | ET/RT PAPILLOTOME | Jul 22, 1986 | Substantially Equivalent |
| K860582 | TBI NEEDLE | Mar 4, 1986 | Substantially Equivalent |
| K844074 | HOBBS MEDICAL POLYPECTOMY SNARE | Jan 3, 1985 | Substantially Equivalent |