REUSABLE HANDLE FOR LAPAROSCOPIC INST. W/ROTATING
FDA 510(k) clearance K930571 · decided 1994-02-01
Clearance details
- K-number
- K930571
- Device name
- REUSABLE HANDLE FOR LAPAROSCOPIC INST. W/ROTATING
- Applicant
- Numed Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-02-04
- Decision date
- 1994-02-01
- Days to decision
- 362 days
- Clearance type
- Traditional
- Product code
- HFI
- Device class
- 2
- Regulation number
- 884.4160
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Independence, OH, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ENDOPLUS hand-held laparoscopic instruments (K151567) | Endoplus | 2015-12-23 |
| FORCEPS FOR LAPAROSCOPIC SURGERY OB/GYN USE (K925960) | Zinnanti Surgical Instruments, Inc. | 1994-06-07 |
| SCISSORS FOR LAPAROSCOPIC SURGERY OB/GYN USE (K925957) | Zinnanti Surgical Instruments, Inc. | 1994-06-07 |
| COOK LAPAROSCOPIC MINI RETRACTOR SET (K936026) | Cook Urological, Inc. | 1994-03-11 |
| LAPAROSCOPIC INSTRUMENTS (K925114) | Endo Technic Corp. | 1994-02-28 |
| DIAMOND-SHARP(R) TROCARS (K924148) | Snowden-Pencer | 1994-02-28 |
| CANON 60 DEGREE FUNDUS CAMERA CF-60S (K844053) | Canon USA, Inc. | 1984-12-19 |
Recalls involving this device
No recalls on record reference this clearance.