FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INFUSION ASPIRATION VITRECTOMY SYS
K Number: K843391
·
Decision Dec 19, 1984
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
148
Applicant Total
22
Review Days
112
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Basic Information
- Device Name
- INFUSION ASPIRATION VITRECTOMY SYS
- K Number
- K843391
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4150
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Medical Instrument Development Laboratories, Inc.
- Date Received
- August 29, 1984
- Decision Date
- December 19, 1984
- Product Code
- HQE
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | FDA class 2 | Ophthalmic |
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Other Clearances by Medical Instrument Development Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K102222 | ULTIMATE VIT ENHAMCER (UVE) | Apr 8, 2011 | Substantially Equivalent |
| K020911 | MID LABS AUTONOMOUS VIT ENHANCER (AVE) | Apr 29, 2002 | Substantially Equivalent |
| K992943 | VIT ENHANCER | Dec 10, 1999 | Substantially Equivalent |
| K971067 | DIGI-INJECTOR | Sep 19, 1997 | Substantially Equivalent |
| K950287 | UNIVIT PROBE | Apr 10, 1995 | Substantially Equivalent |
| K934600 | MICRODRIVE | Jul 27, 1994 | Substantially Equivalent |
| K932669 | SUPRA-VIT(TM) | Jun 3, 1994 | Substantially Equivalent |
| K932131 | MID LABS TWIN ILLUMINATOR | Apr 1, 1994 | Substantially Equivalent |
| K924222 | MID LABS, INC. VIT MATE | Jan 27, 1993 | Substantially Equivalent |
| K851610 | COMBINED MVS SYSTEMS | Jul 22, 1985 | Substantially Equivalent |