TIK EXTRAKTOR
FDA 510(k) clearance K895212 · decided 1989-09-27
Clearance details
- K-number
- K895212
- Device name
- TIK EXTRAKTOR
- Applicant
- Instruments of Sweden, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-08-18
- Decision date
- 1989-09-27
- Days to decision
- 40 days
- Clearance type
- Traditional
- Product code
- HTD
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Stamford, CT, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Instruments of Sweden
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| THE NEEDLE CATCHER (K051281) | E.D.Medical , Ltd. | 2005-09-08 |
| SEMKIN BIPOLAR FORCEP (K974594) | Titan Mfg., Inc. | 1998-06-24 |
| CUSHING BAYONET, INSULATED BIPOLAR FORCEP (K974595) | Titan Mfg., Inc. | 1998-06-24 |
| SEMKIN INSULATED BIPOLAR FORCEP (K974593) | Titan Mfg., Inc. | 1998-06-24 |
| MARLOW/REDDICK LAPAROSCOPIC GRASPING FORCEPS (K913964) | Marlo Surgical Technology | 1991-10-23 |
| CLAW (5MM/10MM) ATRAUMATIC GRASP/MICRO FORCEPS (K911180) | Northgate Technologies, Inc. | 1991-03-29 |
| HEMORRHOIDAL FORCEPS (K890373) | Kinetic Medical Products | 1989-02-03 |
| GALL STONE FORCEPS (K890369) | Kinetic Medical Products | 1989-02-03 |
| TUBING CLAMP FORCEPS (K890244) | Kinetic Medical Products | 1989-01-27 |
| BONE CUTTING FORCEPS, SINGLE-ACTION (K890258) | Kinetic Medical Products | 1989-01-27 |
| LUNG FORCEPS (K890262) | Kinetic Medical Products | 1989-01-27 |
| CATHETER FORCEPS (K890238) | Kinetic Medical Products | 1989-01-27 |
Recalls involving this device
No recalls on record reference this clearance.