FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LITHOTRITE
K Number: K760273
·
Decision Dec 6, 1976
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
0
Applicant Total
41
Review Days
137
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
- LITHOTRITE
- K Number
- K760273
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- V. Mueller O.V. Baxter Healthcare Corp.
- Date Received
- July 22, 1976
- Decision Date
- December 6, 1976
- Product Code
- FGK
- 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 |
|---|---|---|---|
| FGK | Tripsor, Stone, Bladder | FDA class 2 | Gastroenterology, Urology |
Other Clearances by V. Mueller O.V. Baxter Healthcare Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K803292 | FIELD SUCTION DISSECTOR | Jan 29, 1981 | Substantially Equivalent |
| K792383 | KELMAN DIPSTICK | Dec 11, 1979 | Substantially Equivalent |
| K771197 | NORTON ENDOTRACHEAL | Aug 16, 1977 | Substantially Equivalent |
| K771302 | PFISTER-SCHWARTZ STONE RETRIEVER | Aug 2, 1977 | Substantially Equivalent |
| K770959 | BOUGIE, FILIFORM, JACKSON | Jun 14, 1977 | Substantially Equivalent |
| K770280 | CORD, ELECTROSURGICAL-STERILE & DISPOS. | Apr 15, 1977 | Substantially Equivalent |
| K760851 | CONVERSE ALTAR RETRACTOR | Mar 10, 1977 | Substantially Equivalent |
| K761242 | TEFLON COATED RESECTOSCOPE SHEATH | Dec 16, 1976 | Substantially Equivalent |
| K760172 | OBTURATOR, VISUAL | Dec 2, 1976 | Substantially Equivalent |
| K760180 | FORCEPS, GRASPING | Dec 2, 1976 | Substantially Equivalent |