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FDA 510(k)

GIANTURCO-HELFRICH HERNIS MESH

K-Number: K931936 · 1994-01-10

ApplicantCook, Inc.
Decision Date1994-01-10
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GIANTURCO-HELFRICH HERNIS MESH is the device name listed in this FDA 510(k) record. The listed applicant is Cook, Inc.. It received FDA 510(k) clearance on 1994-01-10 under 510(k) number K931936. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GIANTURCO-HELFRICH HERNIS MESH?

GIANTURCO-HELFRICH HERNIS MESH is a medical device that received FDA 510(k) clearance on 1994-01-10. The listed applicant is Cook, Inc.. The 510(k) number is K931936.

When did GIANTURCO-HELFRICH HERNIS MESH receive FDA 510(k) clearance?

GIANTURCO-HELFRICH HERNIS MESH received FDA 510(k) clearance on 1994-01-10, under 510(k) number K931936.

Who is the listed applicant for GIANTURCO-HELFRICH HERNIS MESH?

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 GIANTURCO-HELFRICH HERNIS MESH?

The FDA product code for GIANTURCO-HELFRICH HERNIS MESH is FTL.

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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: FTL)

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.

K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim ProductionK253125Parietene™ Flat Sheet MeshMedtronic - Sofradim ProductionK251955Onflex™ MeshDavol Inc., Subsidiary of C. R. Bard, Inc.K251557Bard® Mesh; Bard® Mesh Pre-ShapedDavol, Inc.K250869Parietene™ Macroporous Mesh (PPM5050 )Sofradim ProductionK250098Bard Soft Mesh; Bard Soft Mesh Pre-ShapedDavol, Inc.

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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