FiXcision
FDA 510(k) clearance K182664 · decided 2018-12-07
Clearance details
- K-number
- K182664
- Device name
- FiXcision
- Applicant
- Agency For Medical Innovations GmbH
- Decision
- Substantially Equivalent
- Date received
- 2018-09-25
- Decision date
- 2018-12-07
- Days to decision
- 73 days
- Clearance type
- Traditional
- Product code
- KOA
- Device class
- 1
- Regulation number
- 876.4730
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Feldkirch, AT
- 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 |
|---|---|---|
| URETHRAL SUTURE GUIDE (K950267) | Applied Medical Resources | 1995-01-31 |
| LI VASECTOMY (K932465) | Femcare , Ltd. | 1994-03-02 |
| VASOVASOSTOMY SET (K921546) | Cook Urological, Inc. | 1993-07-02 |
| VESITEC SUTURE PASSER (K931181) | Vesitec Medical, Inc. | 1993-05-12 |
| DDV LIGATOR (K921304) | North American Medical, Inc. | 1992-10-05 |
| NO-SCALPEL VASCETOMY INSTRUMENTS (K922971) | Pilling Co. | 1992-09-23 |
| BENDEREV PROTECT-A-PASS NEEDLE (K921228) | Eimark Labs, Inc. | 1992-09-14 |
| VAS DILATOR (K922192) | Cook Urological, Inc. | 1992-08-07 |
| GRASPING FORCEPS (K896058) | Annex Medical, Inc. | 1989-12-28 |
| MARLOW ANAL SPECULUM (K891352) | Simpson/Basye, Inc. | 1989-06-23 |
| MICROSURGICAL CYSTOTOME (K890218) | Kinetic Medical Products | 1989-01-27 |
| STOMACH EVACULATOR - EWALD STYLE (K864963) | Medovations, Inc. | 1987-10-14 |
Recalls involving this device
No recalls on record reference this clearance.