FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INSTRUMENT MAKAR GRAVITY ASSIST SYSTEM
K Number: K905365
·
Decision Feb 6, 1991
Classifications
1
FEI Numbers
368
Registration Numbers
368
Same Product Code
40
Applicant Total
28
Review Days
77
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
- INSTRUMENT MAKAR GRAVITY ASSIST SYSTEM
- K Number
- K905365
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6960
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Instrument Makar, Inc.
- Date Received
- November 21, 1990
- Decision Date
- February 6, 1991
- Product Code
- KYZ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| KYZ | Syringe, Irrigating (Non Dental) | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KYZ), ordered by most recent decision date.
OtoSet- Ear Cleaning System
FDA 510(k)
FDA Class 1
·General Hospital
SINGLE CANNULA EXTENDED APPLICATOR
FDA 510(k)
FDA Class 1
·General Hospital
TISSU TRANS HARVEST TUBING
FDA 510(k)
FDA Class 1
·General Hospital
TISSU-TRANS
FDA 510(k)
FDA Class 1
·General Hospital
QS DELIVERY SYSTEM
FDA 510(k)
FDA Class 1
·General Hospital
IRRIGATION SYRINGE KIT
FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by Instrument Makar, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K002600 | LITWIN CRUICATE ANCHOR | Nov 15, 2000 | Substantially Equivalent |
| K980999 | ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANT | Nov 6, 1998 | Substantially Equivalent |
| K963396 | BIOSPHERE SUTURE ANCHOR | May 6, 1997 | Substantially Equivalent |
| K964364 | DISPOSABLE APRON | Feb 25, 1997 | Substantially Equivalent |
| K955835 | FLUID BARRIER BOOT KNEE & ANKLE-HIGH | Nov 19, 1996 | Substantially Equivalent |
| K960555 | BIOASBSORBABLE MINI-SCREW SUTURE ANCHOR | Jul 9, 1996 | Substantially Equivalent |
| K943249 | BIOABSORBABLE INTERFERENCE SCREW | Jul 31, 1995 | Substantially Equivalent |
| K942828 | MAKAR FULL AND HALF FACE SHIELD | Feb 23, 1995 | Substantially Equivalent |
| K944062 | LAPRASCOPIC GRASPER | Feb 23, 1995 | Substantially Equivalent |
| K930980 | INSTRUMENT MAKAR PERFIX INTERFERENCE BONE SCREW | Feb 10, 1994 | Substantially Equivalent for Some Indications |