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FDA 510(k)

COROLENE

K-Number: K052701 · 2005-12-13

ApplicantPeters Surgical
Decision Date2005-12-13
Product CodeGAW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COROLENE is the device name listed in this FDA 510(k) record. The listed applicant is Peters Surgical. It received FDA 510(k) clearance on 2005-12-13 under 510(k) number K052701. The device is classified under product code GAW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COROLENE?

COROLENE is a medical device that received FDA 510(k) clearance on 2005-12-13. The listed applicant is Peters Surgical. The 510(k) number is K052701.

When did COROLENE receive FDA 510(k) clearance?

COROLENE received FDA 510(k) clearance on 2005-12-13, under 510(k) number K052701.

Who is the listed applicant for COROLENE?

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

What is the FDA product code for COROLENE?

The FDA product code for COROLENE is GAW.

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Other records listing Peters Surgical 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.

K233265Monotime and Optime RK232372Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)K071281UNIRING - ANNULOPLASTY RING WITH SIZERSK060465PREMIOK060163CARDIOFLON, CARDIOXYLK062366OPTIME, SINUSORB PGA

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Related Devices (Code: GAW)

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.

K253572STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control DeviceETHICON, Inc.K233355Cypris eXact Suturing SystemCypris MedicalK230746Non absorbable Surgical Polypropylene SutureShandong Haidike Medical Products Co., Ltd.K221280VessealLydus Medical , Ltd.K211178DURAMESH Mesh SutureMsiK192953APTOS Threads – Polypropylene Surgical SuturesAptos, LLC

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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