FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE
K Number: K945738
·
Decision Feb 14, 1995
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
6
Applicant Total
49
Review Days
83
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE
- K Number
- K945738
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Visitec Co.
- Date Received
- November 23, 1994
- Decision Date
- February 14, 1995
- Product Code
- HMT
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| HMT | Drape, Patient, Ophthalmic | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HMT), ordered by most recent decision date.
STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERY
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SOLOS EYESITE DRAPES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OPTHA PREP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SURGICAL DRAPES, OPHTHALMIN
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DRAIN-R-DRAPE(EYE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EYE DRAPE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
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 |
| 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 |
| K923645 | VISITEC ASPIRATING SYRINGE | Sep 30, 1992 | Substantially Equivalent |