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FDA 510(k)

COOK CERVICAL RIPENING BALLOON

K-Number: K131206 · 2013-09-27

ApplicantCook, Inc.
Decision Date2013-09-27
Product CodePFJ
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

COOK CERVICAL RIPENING BALLOON is the device name listed in this FDA 510(k) record. The listed applicant is Cook, Inc.. It received FDA 510(k) clearance on 2013-09-27 under 510(k) number K131206. The device is classified under product code PFJ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COOK CERVICAL RIPENING BALLOON?

COOK CERVICAL RIPENING BALLOON is a medical device that received FDA 510(k) clearance on 2013-09-27. The listed applicant is Cook, Inc.. The 510(k) number is K131206.

When did COOK CERVICAL RIPENING BALLOON receive FDA 510(k) clearance?

COOK CERVICAL RIPENING BALLOON received FDA 510(k) clearance on 2013-09-27, under 510(k) number K131206.

Who is the listed applicant for COOK CERVICAL RIPENING BALLOON?

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 COOK CERVICAL RIPENING BALLOON?

The FDA product code for COOK CERVICAL RIPENING BALLOON is PFJ.

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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 SETK132334TURBO-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/TRAYK130766ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE

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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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