FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
JAIN SUTURE/VESIBAND ORGANIZER
K Number: K905105
·
Decision Jan 31, 1991
Classifications
1
FEI Numbers
840
Registration Numbers
840
Same Product Code
43
Applicant Total
5
Review Days
79
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
- JAIN SUTURE/VESIBAND ORGANIZER
- K Number
- K905105
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Jain Surgical Equipment, Inc.
- Date Received
- November 13, 1990
- Decision Date
- January 31, 1991
- Product Code
- MDM
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| MDM | Instrument, Manual, Surgical, General Use | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MDM), ordered by most recent decision date.
FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
EUTROCHAR
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ANDREWS INTRODUCER, MODEL ASI01
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MICROVASIVE PULMONARY GUIDEWIRE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
LIGHT SABER INTRODUCER NEEDLE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery