LAPAROSCOPIC INST. (SCISSORS,FORCEPS,NEEDLEHOLDER)
FDA 510(k) clearance K925079 · decided 1994-08-24
Clearance details
- K-number
- K925079
- Device name
- LAPAROSCOPIC INST. (SCISSORS,FORCEPS,NEEDLEHOLDER)
- Applicant
- Endo Technic Corp.
- Decision
- Substantially Equivalent
- Date received
- 1992-10-07
- Decision date
- 1994-08-24
- Days to decision
- 686 days
- Clearance type
- Traditional
- Product code
- HET
- Device class
- 2
- Regulation number
- 884.1720
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Northbrook, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ENDOPLUS; Precision Laparoscopic Instruments; REF 346VA; Description 5mm Atraumatic Graspe recall (Z-2264-2013) | Endoplus, Inc. | 2013-09-21 |
| ENDOPLUS; Precision Laparoscopic Instruments; REF 345VA; Description 5 mm Traumatic Graspe recall (Z-2265-2013) | Endoplus, Inc. | 2013-09-21 |