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FDA 510(k)

PARE ENDOSCOPIC SUTURING SYSTEM

K-Number: K003102 · 2001-02-27

ApplicantPare Surgical, Inc.
Decision Date2001-02-27
Product CodeOCW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PARE ENDOSCOPIC SUTURING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Pare Surgical, Inc.. It received FDA 510(k) clearance on 2001-02-27 under 510(k) number K003102. The device is classified under product code OCW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARE ENDOSCOPIC SUTURING SYSTEM?

PARE ENDOSCOPIC SUTURING SYSTEM is a medical device that received FDA 510(k) clearance on 2001-02-27. The listed applicant is Pare Surgical, Inc.. The 510(k) number is K003102.

When did PARE ENDOSCOPIC SUTURING SYSTEM receive FDA 510(k) clearance?

PARE ENDOSCOPIC SUTURING SYSTEM received FDA 510(k) clearance on 2001-02-27, under 510(k) number K003102.

Who is the listed applicant for PARE ENDOSCOPIC SUTURING SYSTEM?

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

What is the FDA product code for PARE ENDOSCOPIC SUTURING SYSTEM?

The FDA product code for PARE ENDOSCOPIC SUTURING SYSTEM is OCW.

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Related Devices (Code: OCW)

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.

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Official Source

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

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