COOK HYSTEROCATH(TM)
FDA 510(k) clearance K884291 · decided 1988-12-08
Clearance details
- K-number
- K884291
- Device name
- COOK HYSTEROCATH(TM)
- Applicant
- Cook, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-10-12
- Decision date
- 1988-12-08
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- KNA
- Device class
- 2
- Regulation number
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Bloomington, IN, 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 |
|---|---|---|
| PANPAC WORD/BARTHOLIN CATHETER (K130087) | Panpac Medical Corporation | 2014-01-10 |
| COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED) (K102141) | Cook Urological, Inc. | 2011-05-06 |
| GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER (K093904) | Glenveigh Surgical, LLC | 2010-04-14 |
| COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400 (K082939) | Cook Urological, Inc. | 2009-09-03 |
| BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500 (K062438) | Cook Ob/Gyn | 2006-10-27 |
| EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01 (K060289) | Frontline Medical | 2006-07-07 |
| TAMPONADE UTERINE BALLOON CATHETER SET (K013597) | Cook Ob/Gyn | 2002-04-17 |
| DND 202 MANUAL UROLOGICAL DIGITAL NEEDLE DRIVER (K014248) | Urogyn , Ltd. | 2002-03-21 |
| DND 101 (K001590) | Urogyn , Ltd. | 2000-08-02 |
| DR. JAHANGER'S CUTTER (K990738) | M.S. Jahanger, MD | 1999-10-29 |
| BERACLAMP, MODEL BC-1 (K990045) | Poamax LLC | 1999-05-24 |
| SCC-23 SAFETY CLAMP AND CUTTER (K982464) | Women First Healthcare, Inc. | 1998-08-11 |
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 |