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FDA 510(k)

GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIR

K-Number: K013718 · 2002-01-08

ApplicantGynecare, A Div. of Ethicon, Inc.
Decision Date2002-01-08
Product CodeOTO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIR is the device name listed in this FDA 510(k) record. The listed applicant is Gynecare, A Div. of Ethicon, Inc.. It received FDA 510(k) clearance on 2002-01-08 under 510(k) number K013718. The device is classified under product code OTO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIR?

GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIR is a medical device that received FDA 510(k) clearance on 2002-01-08. The listed applicant is Gynecare, A Div. of Ethicon, Inc.. The 510(k) number is K013718.

When did GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIR receive FDA 510(k) clearance?

GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIR received FDA 510(k) clearance on 2002-01-08, under 510(k) number K013718.

Who is the listed applicant for GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIR?

The FDA 510(k) record lists Gynecare, A Div. of Ethicon, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIR?

The FDA product code for GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIR is OTO.

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Other records listing Gynecare, A Div. of Ethicon, 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.

K040302VERSAPOINT RESECTOSCOPIC SYSTEM

Related Devices (Code: OTO)

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.

K171271Polyform Synthetic MeshBoston Scientific CorporationK132061RESTORELLE M, RESTORELLE XLColoplast Corp.K123028VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESHCaldera Medical, Inc.K123914RESTORELLE Y CONTOURColoplast A/SK123337VERTESSA LITE 10 X 20CM, VERTESSA LITE 11 X 30CMCaldera MedicalK122794UPSYLON Y MESHBoston Scientific Corp

Official Source

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