FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IMC 5.0MM IRRIGATION/ASPIRATION PROBE W/HOLES
K Number: K933306
·
Decision Oct 5, 1993
Classifications
1
FEI Numbers
213
Registration Numbers
213
Same Product Code
95
Applicant Total
14
Review Days
90
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Basic Information
- Device Name
- IMC 5.0MM IRRIGATION/ASPIRATION PROBE W/HOLES
- K Number
- K933306
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4680
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Inman Medical Corp.
- Date Received
- July 7, 1993
- Decision Date
- October 5, 1993
- Product Code
- GCY
- 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 |
|---|---|---|---|
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Inman Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K933171 | INMAN IRRIGATION TAPERED PROBE | Apr 29, 1994 | Substantially Equivalent |
| K933169 | INMAN ENDOSCOPIC BLUNT DISSECTOR | Apr 19, 1994 | Substantially Equivalent |
| K933094 | INSUFFLATOR TUBING KIT W/FILTER | Apr 18, 1994 | Substantially Equivalent |
| K933382 | IMC CABLE/WIRE COVER | Jan 27, 1994 | Substantially Equivalent |
| K933774 | IMC SALINE WET DRESSING | Nov 8, 1993 | Substantially Equivalent for Some Indications |
| K933305 | IMC 5.0MM IRRIGATION/ASPIRATION PROBE | Oct 5, 1993 | Substantially Equivalent |
| K933170 | INMAN POOLE TIP SUCTION PROBE W/TUBING KIT | Sep 16, 1993 | Substantially Equivalent |
| K932762 | 10.0MM SUCTION/IRRIGATION PROBE & TUBING KIT | Aug 31, 1993 | Substantially Equivalent |
| K933371 | IMC ENDOSCOPIC INSTRUMENT HOLDER | Aug 6, 1993 | Substantially Equivalent |
| K921291 | INMAN MEDICAL PACKING STRIP | Jan 21, 1993 | Substantially Equivalent |