FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MENISCAL SUTURE GUN
K Number: K832978
·
Decision Dec 12, 1983
Classifications
1
FEI Numbers
236
Registration Numbers
236
Same Product Code
27
Applicant Total
28
Review Days
101
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Basic Information
- Device Name
- MENISCAL SUTURE GUN
- K Number
- K832978
- 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
- September 2, 1983
- Decision Date
- December 12, 1983
- Product Code
- GDF
- 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 |
|---|---|---|---|
| GDF | Guide, Needle, Surgical | FDA class 1 | General, Plastic Surgery |
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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 |