FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INSTRUMENT MAKAR DISPOSALBE LOOP
K Number: K853597
·
Decision Sep 23, 1985
Classifications
1
FEI Numbers
231
Registration Numbers
231
Same Product Code
66
Applicant Total
28
Review Days
27
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Basic Information
- Device Name
- INSTRUMENT MAKAR DISPOSALBE LOOP
- K Number
- K853597
- 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
- August 27, 1985
- Decision Date
- September 23, 1985
- Product Code
- KDC
- 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 |
|---|---|---|---|
| KDC | Instrument, Surgical, Disposable | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KDC), ordered by most recent decision date.
DISPOSABLE SURGICAL SCISSORS AND FORCEPS
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SURGIMED BREAST LOCALIZATION NEEDLE WIRE SET
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THERMUFF BAG
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MANUAL SURGICAL INSTRUMENTS
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DISPOSABLE CAUTERY ABRASIVE PAD
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INSTRUMENT ORGANIZER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Instrument Makar, Inc.
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|---|---|---|---|
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| 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 |