FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ACUFEX ARTHROSCOPIC SHAVER
K Number: K844130
·
Decision Mar 21, 1985
Classifications
1
FEI Numbers
67
Registration Numbers
67
Same Product Code
55
Applicant Total
78
Review Days
149
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
- ACUFEX ARTHROSCOPIC SHAVER
- K Number
- K844130
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Acufex Microsurgical, Inc.
- Date Received
- October 23, 1984
- Decision Date
- March 21, 1985
- Product Code
- HSZ
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| HSZ | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HSZ), ordered by most recent decision date.
EMS SWISS ORTHOCLAST
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CURVTEK TSR SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ALIGNMENT INSTRUMENT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ASPACH 65,000 (MODIFICATION)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SODEM HIGH SPEED SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ETHICON DRILL BIT AND DRILL GUIDE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Acufex Microsurgical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K961555 | ACUFEX TAG BIOABSORBABLE ANCHORS | Jul 10, 1996 | Substantially Equivalent |
| K961853 | PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSER | Jun 21, 1996 | Substantially Equivalent |
| K954246 | ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW | Feb 15, 1996 | Substantially Equivalent for Some Indications |
| K952535 | ACUFEX ENDOBUTTON TAPE | Feb 8, 1996 | Substantially Equivalent for Some Indications |
| K953276 | ACUFEX TAG DELIVERY SYSTEM | Oct 5, 1995 | Substantially Equivalent |
| K953459 | ACUFEX TAG ANCHOR | Aug 23, 1995 | Substantially Equivalent |
| K941740 | ACUFEX ROTATOR CUFF FIXATION BUTTON | Jun 30, 1995 | Substantially Equivalent |
| K944500 | ACUFEX PATELLAR BONE BLOCK SIZER | Jun 12, 1995 | Substantially Equivalent |
| K951859 | ACUFEX ENDOBUTTON PACK | Jun 9, 1995 | Substantially Equivalent |
| K946346 | ACUFEX TAG(R) BIOABSORBABLE ANCHORS | Apr 26, 1995 | Substantially Equivalent |