FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELECTROSURGICAL MENISCUS CUTTER (EMC) MOD. AMC-100
K Number: K870269
·
Decision Mar 9, 1987
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
59
Review Days
45
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Basic Information
- Device Name
- ELECTROSURGICAL MENISCUS CUTTER (EMC) MOD. AMC-100
- K Number
- K870269
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- American Bentley
- Date Received
- January 23, 1987
- Decision Date
- March 9, 1987
- Product Code
- GEI
- 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
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Other Clearances by American Bentley
| K Number | Device Name | ||
|---|---|---|---|
| K872896 | UMBILICAL ARTERY OXYGEN PROBE MODEL UAP-100 | Feb 12, 1988 | Substantially Equivalent |
| K873923 | INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER | Nov 6, 1987 | Substantially Equivalent |
| K872167 | CARDIOTOMY/MEDIASTINAL AUTO. RESERVOIR CATR-3500 | Sep 1, 1987 | Substantially Equivalent |
| K870804 | CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-100 | Sep 1, 1987 | Substantially Equivalent |
| K872133 | OXYGENATOR MODEL NO. BENTLEY 5 PLUS | Aug 24, 1987 | Substantially Equivalent |
| K870911 | INDWELLING BLOOD CARBONDIOXIDE PARTIAL PRES. ANALY | May 29, 1987 | Substantially Equivalent |
| K863249 | OXYGENATOR MODEL NO. BENTLEY-10 PLUS | Oct 20, 1986 | Substantially Equivalent |
| K861641 | HEPARIN-COATED EXTRACORPOREAL CIRCUITS | Sep 29, 1986 | Substantially Equivalent |
| K862549 | ARTERIAL BLOOD FILTER HOLDER MODEL NO. AF-HE | Jul 15, 1986 | Substantially Equivalent |
| K860673 | OXYGENATOR MODEL NOS. BENTLEY-10A & BENTLEY-10B | Jun 26, 1986 | Substantially Equivalent |