FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STAPLE REMOVAL KIT
K Number: K963234
·
Decision Oct 21, 1996
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
18
Applicant Total
8
Review Days
63
Basic Information
- Device Name
- STAPLE REMOVAL KIT
- K Number
- K963234
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4760
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- CONTINENTAL MEDICAL LABORATORIES, INC.
- Date Received
- August 19, 1996
- Decision Date
- October 21, 1996
- Product Code
- GDT
- 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 |
|---|---|---|---|
| GDT | Staple, Removable (Skin) | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GDT), ordered by most recent decision date.
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AUTO SUTURE(R) POLYMER SKIN GRAFT STAPLER*
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APPOSE UNITY STERILE DISPOSABLE SKIN STAPLER
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Other Clearances by CONTINENTAL MEDICAL LABORATORIES, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K964827 | PROD. NO. 01-132 - SUTURE REMOVAL KIT | Feb 14, 1997 | Substantially Equivalent |
| K963443 | PROD. NO. 02-031 - LACERATION TRAY | Oct 17, 1996 | Substantially Equivalent |
| K962078 | TRACHEOSTOMY CLEANING TRAY W/SUCTION CATHETER | Oct 11, 1996 | Unknown |
| K954728 | PROD NO. 01-1694 - 4X4 FOAM DRESSING | Sep 23, 1996 | Substantially Equivalent for Some Indications |
| K962073 | URETHRAL CATHETERIZATION TRAY/UNIVERSAL URETHRAL CATH TRAY | Jun 21, 1996 | Substantially Equivalent |
| K952335 | WOUND CARE MANAGEMENT KITS | Jun 14, 1995 | Substantially Equivalent |
| K905123 | G-TUBE DRESSING CHANGE TRAY | Mar 27, 1991 | Substantially Equivalent |