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FDA 510(k)

REIGEL TUNNELING DEVICE

K-Number: K962761 · 1996-10-11

ApplicantCook, Inc.
Decision Date1996-10-11
Product CodeGYK
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

REIGEL TUNNELING DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Cook, Inc.. It received FDA 510(k) clearance on 1996-10-11 under 510(k) number K962761. The device is classified under product code GYK. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REIGEL TUNNELING DEVICE?

REIGEL TUNNELING DEVICE is a medical device that received FDA 510(k) clearance on 1996-10-11. The listed applicant is Cook, Inc.. The 510(k) number is K962761.

When did REIGEL TUNNELING DEVICE receive FDA 510(k) clearance?

REIGEL TUNNELING DEVICE received FDA 510(k) clearance on 1996-10-11, under 510(k) number K962761.

Who is the listed applicant for REIGEL TUNNELING DEVICE?

The FDA 510(k) record lists Cook, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REIGEL TUNNELING DEVICE?

The FDA product code for REIGEL TUNNELING DEVICE is GYK.

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Other records listing Cook, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K133634SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SETK132020ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETERK131201ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE ANCHOR SETK131206COOK CERVICAL RIPENING BALLOONK132334TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SETK122091COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY

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Related Devices (Code: GYK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K934391V/P AND L/P CATHETER PASSERSRadionics, Inc.K930606PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSERPudenz-Schulte Medical Research Corp.K932273CORDIS TUNNELERCordis Corp.K895868HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSEBaxter Healthcare CorpK883607PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETERCodman & Shurtleff, Inc.K873771HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTROAmerican V. Mueller

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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