FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLEXIBLE GRASPING FORCEPS
K Number: K941161
·
Decision May 4, 1994
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
238
Applicant Total
28
Review Days
54
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Basic Information
- Device Name
- FLEXIBLE GRASPING FORCEPS
- K Number
- K941161
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4680
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Surgical Technologies, Inc.
- Date Received
- March 11, 1994
- Decision Date
- May 4, 1994
- Product Code
- EOQ
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| EOQ | Bronchoscope (Flexible Or Rigid) | FDA class 2 | Ear, Nose, Throat |
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Other Clearances by Surgical Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K941992 | CYSTOSCOPE | Nov 30, 1995 | Substantially Equivalent |
| K942029 | ARTHROSCOPE | Nov 8, 1995 | Substantially Equivalent |
| K946136 | INFINITECH LIGHTED INFUSION CANNULA | Oct 2, 1995 | Substantially Equivalent |
| K952566 | OSCILFLATOR | Aug 31, 1995 | Substantially Equivalent |
| K951918 | SURGICAL TECHNOLOGIES, INC. SYRINGE | Jul 20, 1995 | Substantially Equivalent |
| K950683 | ARTHROGRAM TRAY | May 6, 1995 | Substantially Equivalent |
| K946135 | INFINITECH ASPIRATING LASER PROBE | Apr 18, 1995 | Substantially Equivalent |
| K946181 | INFINITECH SOFT TIP FLUTE NEEDLE | Mar 14, 1995 | Substantially Equivalent |
| K942030 | BIOPSY SCISSORS | Jun 27, 1994 | Substantially Equivalent |
| K942482 | PRESSURE MONITORING EXTENSION | Jun 14, 1994 | Substantially Equivalent |