FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FLUTED SUCTION MENISCAL CUTTER
K Number: K850789
·
Decision Jun 28, 1985
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
28
Applicant Total
27
Review Days
122
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
- FLUTED SUCTION MENISCAL CUTTER
- K Number
- K850789
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- T. Korossurgical Instruments Corp.
- Date Received
- February 26, 1985
- Decision Date
- June 28, 1985
- Product Code
- KIJ
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| KIJ | Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KIJ), ordered by most recent decision date.
SMARTO
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
INSURGICAL SINGLE USE POWER EQUIPMENT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SMARTO
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
STRYKER 2115 REPLACEMENT BATTERY (2115)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ACUMED BONE GRAFT SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by T. Korossurgical Instruments Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K001915 | GRAFT MARKER RING | Apr 27, 2001 | Substantially Equivalent |
| K002755 | NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE | Dec 4, 2000 | Substantially Equivalent |
| K954016 | VIDEOSCOPE W/IRRIGATION SHEATH | Jan 25, 1996 | Substantially Equivalent for Some Indications |
| K953998 | DISCETOME TISSUE ASPIRATOR | Dec 4, 1995 | Substantially Equivalent |
| K954052 | ARTHROSCOPIC GRASPER, CUP FORCEPS AND CURETTES | Nov 6, 1995 | Substantially Equivalent for Some Indications |
| K954014 | PERCUTANEOUS DISCECTOMY CANNULA SYSTEM | Nov 6, 1995 | Substantially Equivalent for Some Indications |
| K935529 | CERVICAL SELF-RETAINING RETRACTOR | Mar 22, 1994 | Substantially Equivalent |
| K926585 | THOROCOSCOPY SELF-RETAINING RETRACTOR | Aug 6, 1993 | Substantially Equivalent |
| K931262 | REUSABLE/INTERCHANGEABLE SHAFT, ENDOSCOPIC SCISSOR | Aug 6, 1993 | Substantially Equivalent |
| K926583 | REUSABLE ENDOSCOPIC SCISSORS, GRASPER-MONOPOLAR | Aug 6, 1993 | Substantially Equivalent |