DEFLECTING WIRE GRASPER
FDA 510(k) clearance K903707 · decided 1990-09-26
Clearance details
- K-number
- K903707
- Device name
- DEFLECTING WIRE GRASPER
- Applicant
- Cook, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-08-15
- Decision date
- 1990-09-26
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- HCZ
- Device class
- 2
- Regulation number
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Spencer, IN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Cook
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 |
|---|---|---|
| Fetzer Medical Gynecological Forceps (K172661) | Fetzer Medical GmbH & Co. KG | 2018-05-08 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Zenith® Iliac Branch (P020018/S064) | Cook, Inc. | 2025-05-30 |
| ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTINO SYSTEM (P020018/S065) | Cook, Inc. | 2025-04-09 |
| Zenith Fenestrated AAA Endovascular Graft (P020018/S063) | Cook, Inc. | 2024-04-29 |
| Zenith® Fenestrated AAA Endovascular Graft, Zenith® Flex AAA Endovascular System (P020018/S061) | Cook, Inc. | 2023-12-14 |
| Zenith® Fenestrated AAA Endovascular Graft (ZFEN), Zenith® Flex AAA Endovascular System (P020018/S062) | Cook, Inc. | 2023-12-13 |
| Zenith Fenestrated AAA Endovascular Graft (P020018/S060) | Cook, Inc. | 2022-01-20 |
| Zenith AAA Endovascular Graft (P020018/S059) | Cook, Inc. | 2020-10-08 |
| ZENITH FLEX AAA ENDOVASCULAR GRAFT (P020018/S055) | Cook, Inc. | 2018-10-10 |