FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VISI - STICK OPHTHALMIC SUTURE RETAINER TAPE
K Number: K902010
·
Decision Jun 20, 1990
Classifications
1
FEI Numbers
972
Registration Numbers
972
Same Product Code
186
Applicant Total
49
Review Days
48
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Basic Information
- Device Name
- VISI - STICK OPHTHALMIC SUTURE RETAINER TAPE
- K Number
- K902010
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5240
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Visitec Co.
- Date Received
- May 3, 1990
- Decision Date
- June 20, 1990
- Product Code
- KGX
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| KGX | Tape And Bandage, Adhesive | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KGX), ordered by most recent decision date.
SERAGARD INJECTION PATCH
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FDA Class 1
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CARE BAND ANTIBACTERIAL BANDAGES
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FDA Class 1
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SYVEK PATCH
FDA 510(k)
FDA Class 1
·General Hospital
ADHESIVE BANDAGES WITH OTC DRUG
FDA 510(k)
FDA Class 1
·General Hospital
TARGETT PATCH
FDA 510(k)
FDA Class 1
·General Hospital
PARALLEL
FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by Visitec Co.
| K Number | Device Name | ||
|---|---|---|---|
| K953394 | VISITEC COLLAR BUTTON CATHETER {GRIFFITHS} | Oct 12, 1995 | Substantially Equivalent |
| K945114 | VISITEC SCLERAL PLUG | Feb 23, 1995 | Substantially Equivalent |
| K945738 | VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE | Feb 14, 1995 | Substantially Equivalent |
| K945172 | VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS | Jan 17, 1995 | Substantially Equivalent |
| K942234 | VISITEC PRECISE-POINT | Jul 12, 1994 | Substantially Equivalent |
| K934269 | FIBEROPTIC ILLUMINATED INSTRUMENTS | May 17, 1994 | Substantially Equivalent |
| K940210 | VISITEC EYE PAD | Mar 7, 1994 | Substantially Equivalent |
| K933872 | VISI-SPEAR EYE SPONGE | Dec 27, 1993 | Substantially Equivalent |
| K923972 | OPHTHALMIC FLUID DISTRIBUTION SETS | Nov 4, 1992 | Substantially Equivalent |
| K922530 | VISITEC MICROSURGICAL SUTURE | Oct 20, 1992 | Substantially Equivalent |