FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SURGICAL STAPLE REMOVER
K Number: K811120
·
Decision May 5, 1981
Classifications
1
FEI Numbers
231
Registration Numbers
231
Same Product Code
66
Applicant Total
27
Review Days
11
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
- SURGICAL STAPLE REMOVER
- K Number
- K811120
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Acme United Corp.
- Date Received
- April 24, 1981
- Decision Date
- May 5, 1981
- Product Code
- KDC
- 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 |
|---|---|---|---|
| KDC | Instrument, Surgical, Disposable | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KDC), ordered by most recent decision date.
DISPOSABLE SURGICAL SCISSORS AND FORCEPS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SURGIMED BREAST LOCALIZATION NEEDLE WIRE SET
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
THERMUFF BAG
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MANUAL SURGICAL INSTRUMENTS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DISPOSABLE CAUTERY ABRASIVE PAD
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
INSTRUMENT ORGANIZER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Acme United Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K961323 | LYOFOAM EXTRA C ODOR ABSORBING WOUND DRESSING | Jun 19, 1996 | Substantially Equivalent |
| K961452 | LYOFOAM EXTRA 'A' STERILE ADHESIVE WOUND DRESSING | May 31, 1996 | Substantially Equivalent |
| K952565 | LYOFOAM EXTRA | Nov 14, 1995 | Substantially Equivalent for Some Indications |
| K895764 | MODIFIED LYOFOAM WOUND DRESSINGS | Sep 10, 1990 | Substantially Equivalent for Some Indications |
| K871740 | LYOSHEET SURGICAL SHEET FOR BURNS | Jun 9, 1987 | Substantially Equivalent |
| K864084 | LYOFOAM C ODOR-ABSORBING DRESSING | Nov 21, 1986 | Substantially Equivalent for Some Indications |
| K860085 | LYOFOAM WOUND DRESSINGS | Jun 27, 1986 | Substantially Equivalent for Some Indications |
| K860818 | ONE TIME ENTERAL FEEDING BAG | May 15, 1986 | Substantially Equivalent |
| K861015 | ONE TIME HYPERAL & CATHETER DRESSING CHANGE TRAYS | Apr 22, 1986 | Substantially Equivalent |
| K842186 | ACU-DERM TRANSPARENT WOUND DRESSING | Aug 24, 1984 | Substantially Equivalent |