DISPOSABLE RE-NEW FORCEPS
FDA 510(k) clearance K981389 · decided 1998-05-29
Clearance details
- K-number
- K981389
- Device name
- DISPOSABLE RE-NEW FORCEPS
- Applicant
- Microline Pentax, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-04-16
- Decision date
- 1998-05-29
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Wellesley, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips Ref 3221 recall (Z-1986-2014) | Microline Surgical, Inc. | 2014-07-02 |
| Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips (Reusable) Ref 3222 recall (Z-1987-2014) | Microline Surgical, Inc. | 2014-07-02 |
| Microline Renew Fenestrated Control Tip Grasper, Single Patient Use, Product Number: 3222 recall (Z-1635-2014) | Microline Surgical | 2014-05-20 |
| Microline Surgical ReNew Laproscopic Long Fenestrated Grasper Forceps Tip Ref: 3262 The Re recall (Z-3085-2011) | Microline Surgical, Inc. | 2011-08-29 |
| Microline Surgical ReNew Laproscopic ControlTip Atraumatic Fenestrated Grasper Forceps Tip recall (Z-3086-2011) | Microline Surgical, Inc. | 2011-08-29 |