FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURGICAL DRAPES, OPHTHALMIN
K Number: K854613
·
Decision Feb 13, 1986
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
6
Applicant Total
2
Review Days
87
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
- SURGICAL DRAPES, OPHTHALMIN
- K Number
- K854613
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Charles Atkins & Co.
- Date Received
- November 18, 1985
- Decision Date
- February 13, 1986
- 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.
VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
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
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 Charles Atkins & Co.
| K Number | Device Name | ||
|---|---|---|---|
| K853759 | CUSTOM PROCEDURAL TRAY PROCEDURAL KIT | Nov 17, 1985 | Unknown |