FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
UNI-PORT
K Number: K880543
·
Decision Jul 1, 1988
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
39
Applicant Total
10
Review Days
143
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Basic Information
- Device Name
- UNI-PORT
- K Number
- K880543
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4360
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Surgeon Surgical Instrumentation, Inc.
- Date Received
- February 9, 1988
- Decision Date
- July 1, 1988
- Product Code
- KYG
- 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 |
|---|---|---|---|
| KYG | Device, Irrigation, Ocular Surgery | FDA class 1 | Ophthalmic |
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Other Clearances by Surgeon Surgical Instrumentation, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K954241 | SURGIN GENISIS PHACOEMULSIFIER | Dec 1, 1995 | Substantially Equivalent |
| K932281 | VERRES NEEDLE | Aug 6, 1993 | Substantially Equivalent |
| K922038 | CO2 INSUFFLATION TUBING | Oct 13, 1992 | Substantially Equivalent |
| K904010 | SURGICAL ASPIRATOR KIT | Nov 21, 1990 | Substantially Equivalent |
| K890447 | HEMORRHAGE OCCLUDOR | Feb 23, 1989 | Substantially Equivalent |
| K881232 | SURGIN EYE SHIELD | Apr 13, 1988 | Substantially Equivalent |
| K861203 | MULTI-SPIKE | Apr 28, 1986 | Substantially Equivalent |
| K852229 | STERILE EYE PACKS OR TRAYS | Jun 7, 1985 | Substantially Equivalent |
| K830859 | I/A KIT | May 2, 1983 | Substantially Equivalent |