Fetzer Medical Gynecological Forceps
FDA 510(k) clearance K172661 · decided 2018-05-08
Clearance details
- K-number
- K172661
- Device name
- Fetzer Medical Gynecological Forceps
- Applicant
- Fetzer Medical GmbH & Co. KG
- Decision
- Substantially Equivalent
- Date received
- 2017-09-05
- Decision date
- 2018-05-08
- Days to decision
- 245 days
- Clearance type
- Traditional
- Product code
- HCZ
- Device class
- 2
- Regulation number
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Tuttlingen, DE
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Fetzer Medical GmbH & Co. KG
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 |
|---|---|---|
| JARIT GYNECOLOGICAL FORCEPS, MILTEX GYNECOLOGICAL FORCEPS, MEISTERHAND GYNECOLOICAL FORCEPS (K134047) | Integra LifeSciences Corporation | 2014-04-11 |
| INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICAL (K092840) | Instrumed International, Inc. | 2009-12-03 |
| FORCEPS, SURGICAL GYNECOLOGICAL (K944055) | Owens Precision Systems, Inc. | 1994-09-20 |
| PEARL PACKING FORCEPS (K941528) | Cook Urological, Inc. | 1994-05-12 |
| CORSON MYOMA GRASPING FORCEPS (K926484) | Thomasville Medical Assoc. | 1994-02-25 |
| Z-CLAMP FORCEPS (K926533) | Thomasville Medical Assoc. | 1994-02-25 |
| HYSTERECTOMY FORCEPS (K926531) | Thomasville Medical Assoc. | 1994-02-25 |
| VARIOUS FORCEPS (K930799) | Thomasville Medical Assoc. | 1994-02-24 |
| OVUM FORCEPS (K926528) | Thomasville Medical Assoc. | 1994-02-24 |
| FORCEPS: MCGRAVEY, MCINDOE, GILLIS (K930039) | Thomasville Medical Assoc. | 1994-02-24 |
| LAPAROSCOPIC FORCEPS (K911474) | United States Endoscopy Group, Inc. | 1991-07-03 |
| DEFLECTING WIRE GRASPER (K903707) | Cook, Inc. | 1990-09-26 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 16600 / Fetzer Surgical Luikart Simpson OB Forceps14" (35.5cm), Item No./Product Code 46-5 recall (Z-0755-2019) | Fetzer Medical GmbH & Co. KG | 2019-01-18 |
| 12002 / Boss Instruments Ltd. Wrigley Obstetric Forceps, 11" (28cm), Item No./Product Code recall (Z-0756-2019) | Fetzer Medical GmbH & Co. KG | 2019-01-18 |
| 16600 / Fetzer Surgical De Lee Obstetric Forceps, 11" (30cm), Item No./Product Code 46-503 recall (Z-0757-2019) | Fetzer Medical GmbH & Co. KG | 2019-01-18 |
| 12002 / Boss Instruments Simpson OB Forceps, short model, 13" (33cm), Item No./Product Cod recall (Z-0758-2019) | Fetzer Medical GmbH & Co. KG | 2019-01-18 |