FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DEBRIDEMENT TRAY, INCISION AND DRAINAGE TRAY
K Number: K963715
·
Decision Nov 27, 1996
Classifications
1
FEI Numbers
159
Registration Numbers
159
Same Product Code
109
Applicant Total
8
Review Days
72
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
- DEBRIDEMENT TRAY, INCISION AND DRAINAGE TRAY
- K Number
- K963715
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Grand Medical Products
- Date Received
- September 16, 1996
- Decision Date
- November 27, 1996
- Product Code
- LRO
- 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 |
|---|---|---|---|
| LRO | General Surgery Tray | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LRO), ordered by most recent decision date.
Medline General Surgery Tray
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Medline Cardiovascular Procedure Kit
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SURGICAL DRAPE KIT - D.I.R.R.A. SRL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AMSINO TRACHEOSTOMY CARE TRAY
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE TRAY
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Grand Medical Products
| K Number | Device Name | ||
|---|---|---|---|
| K963724 | GAUZE SPONGE, NON X-RAY DETECTABLE | Nov 29, 1996 | Substantially Equivalent for Some Indications |
| K963720 | TRACHEOSTOMY KIT | Nov 27, 1996 | Substantially Equivalent |
| K963719 | CENTRAL LINE DRESSING CHANGE TRAY, TPN/CVP DRESSING CHANGE TRAY | Nov 27, 1996 | Substantially Equivalent |
| K963723 | LACERATION TRAY | Nov 27, 1996 | Substantially Equivalent |
| K963714 | GRAND MEDICAL SUTURE REMOVAL KIT | Nov 27, 1996 | Substantially Equivalent |
| K963721 | SKIN SCRUB TRAY | Nov 27, 1996 | Substantially Equivalent |
| K963722 | IV START KIT | Nov 27, 1996 | Substantially Equivalent |