REIGEL TUNNELING DEVICE
FDA 510(k) clearance K962761 · decided 1996-10-11
Clearance details
- K-number
- K962761
- Device name
- REIGEL TUNNELING DEVICE
- Applicant
- Cook, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-07-16
- Decision date
- 1996-10-11
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- GYK
- Device class
- 1
- Regulation number
- 882.4545
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- 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 |
|---|---|---|
| V/P AND L/P CATHETER PASSERS (K934391) | Radionics, Inc. | 1993-11-19 |
| PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER (K930606) | Pudenz-Schulte Medical Research Corp. | 1993-09-10 |
| CORDIS TUNNELER (K932273) | Cordis Corp. | 1993-08-23 |
| HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE (K895868) | Baxter Healthcare Corp | 1989-10-31 |
| PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETER (K883607) | Codman & Shurtleff, Inc. | 1988-09-30 |
| HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO (K873771) | American V. Mueller | 1987-12-18 |
| H-H SUBGALEAL TROCAR (K865075) | Holter-Hausner Intl. | 1987-01-13 |
| H-H CATHETER PASSERS(TACL DESIGN (K853370) | Holter-Hausner Intl. | 1985-09-18 |
| H-H SHUNT INTRODUCER (K853368) | Holter-Hausner Intl. | 1985-09-06 |
| H-H SHUNT PASSERS (K841553) | Holter-Hausner Intl. | 1984-05-14 |
| H-H SHUNT INTRODUCER (K792639) | Holter-Hausner Intl. | 1979-12-31 |
| PERITONEAL INTRODUCER & SHEATH (K771529) | Cordis Corp. | 1977-08-16 |
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 |