FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
I.M. SCALPEL HANDLE
K Number: K810720
·
Decision Apr 3, 1981
Classifications
1
FEI Numbers
430
Registration Numbers
430
Same Product Code
15
Applicant Total
28
Review Days
17
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Basic Information
- Device Name
- I.M. SCALPEL HANDLE
- K Number
- K810720
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Instrument Makar, Inc.
- Date Received
- March 17, 1981
- Decision Date
- April 3, 1981
- Product Code
- GDZ
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GDZ | Handle, Scalpel | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
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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 |