FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EMERGENCY DEPARTMENT LACERATION KIT-
K Number: K802557
·
Decision Nov 12, 1980
Classifications
1
FEI Numbers
329
Registration Numbers
330
Same Product Code
61
Applicant Total
206
Review Days
27
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
- EMERGENCY DEPARTMENT LACERATION KIT-
- K Number
- K802557
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Johnson & Johnson Professionals, Inc.
- Date Received
- October 16, 1980
- Decision Date
- November 12, 1980
- Product Code
- KDD
- 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 |
|---|---|---|---|
| KDD | Kit, Surgical Instrument, Disposable | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KDD), ordered by most recent decision date.
CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
INSTRUMENTS FOR ONE TIME USE - DISPOSABLE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LINE(60-1100) DENVER PARACENTESIS TRAY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CUSTOM CV PACK
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SUTURE SET OR LACERATION TRAYS (PACKS)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Johnson & Johnson Professionals, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K992173 | SIPHONGUARD CSF CONTROL DEVICE | Apr 7, 2000 | Substantially Equivalent |
| K991413 | CODMAN ETHISORB DURA PATCH | Mar 13, 2000 | Substantially Equivalent |
| K991222 | CODMAN MICROSENSOR VENTRICULAR CATHETER KIT | Jul 9, 1999 | Substantially Equivalent |
| K982379 | SUNDT SLIM-LINE ANEURYSM CLIP APPLIER | Dec 18, 1998 | Substantially Equivalent |
| K982812 | G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER) | Dec 4, 1998 | Substantially Equivalent |
| K983141 | CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS | Nov 6, 1998 | Substantially Equivalent |
| K983014 | SUMMIT ACETABULAR SYSTEM | Oct 27, 1998 | Substantially Equivalent |
| K980778 | HAKIM MICRO PROGRAMMABLE VALVE SYSTEM | Jul 17, 1998 | Substantially Equivalent |
| K974739 | HAKIM PROGRAMMABLE VALVE SYSTEM | Jul 1, 1998 | Substantially Equivalent |
| K980801 | J-FX BIPOLAR HEAD | May 29, 1998 | Substantially Equivalent |