FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DISPOSABLE HEMOSTATS
K Number: K821617
·
Decision Jun 21, 1982
Classifications
1
FEI Numbers
182
Registration Numbers
182
Same Product Code
14
Applicant Total
20
Review Days
19
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Basic Information
- Device Name
- DISPOSABLE HEMOSTATS
- K Number
- K821617
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Medcare Products
- Date Received
- June 2, 1982
- Decision Date
- June 21, 1982
- Product Code
- HRQ
- 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 |
|---|---|---|---|
| HRQ | Hemostat | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HRQ), ordered by most recent decision date.
DISPOSABLE HEMOSTATS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
BERNARD VESSEL APPROXIMATOR
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SURGICAL HEMOSTATS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SURGICAL INSTRUMENTS (VARIOUS TYPES & SIZES)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SURGICAL INSTRUMENTS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MEDCARE HEMOSTATS (STRAIGHT, CURVED, MOSQUITO-TIP)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Medcare Products
| K Number | Device Name | ||
|---|---|---|---|
| K841122 | TRACHEOSTOMY CARE TRAY | Apr 25, 1984 | Substantially Equivalent |
| K841124 | DIALYSIS TRAY | Apr 20, 1984 | Substantially Equivalent |
| K841123 | DRESSING CHANGE TRAY | Apr 17, 1984 | Substantially Equivalent |
| K831374 | MED CARE PREP RAZOR | Oct 4, 1983 | Substantially Equivalent |
| K831663 | TISSUE FORCEPS | Sep 26, 1983 | Substantially Equivalent |
| K831664 | PLASTIC THUMB FORCEPS | Sep 12, 1983 | Substantially Equivalent |
| K831665 | DISPOSABLE NEEDLE HOLDER | Sep 12, 1983 | Substantially Equivalent |
| K831661 | DISPOSABLE SCISSORS | Aug 25, 1983 | Substantially Equivalent |
| K831662 | DISPOSABLE HEMOSTAT (STRAIGHT&CURVED | Jul 19, 1983 | Substantially Equivalent |
| K823854 | MEDCARE SUTURE REMOVAL TRAYS | Mar 31, 1983 | Substantially Equivalent |