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FDA 510(k)

INNOVASIVE DEVICES Y-KNOT SUTURE CLIP

K-Number: K973313 · 1997-12-01

ApplicantInnovasive Devices, Inc.
Decision Date1997-12-01
Product CodeOCW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INNOVASIVE DEVICES Y-KNOT SUTURE CLIP is the device name listed in this FDA 510(k) record. The listed applicant is Innovasive Devices, Inc.. It received FDA 510(k) clearance on 1997-12-01 under 510(k) number K973313. 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 INNOVASIVE DEVICES Y-KNOT SUTURE CLIP?

INNOVASIVE DEVICES Y-KNOT SUTURE CLIP is a medical device that received FDA 510(k) clearance on 1997-12-01. The listed applicant is Innovasive Devices, Inc.. The 510(k) number is K973313.

When did INNOVASIVE DEVICES Y-KNOT SUTURE CLIP receive FDA 510(k) clearance?

INNOVASIVE DEVICES Y-KNOT SUTURE CLIP received FDA 510(k) clearance on 1997-12-01, under 510(k) number K973313.

Who is the listed applicant for INNOVASIVE DEVICES Y-KNOT SUTURE CLIP?

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

What is the FDA product code for INNOVASIVE DEVICES Y-KNOT SUTURE CLIP?

The FDA product code for INNOVASIVE DEVICES Y-KNOT SUTURE CLIP is OCW.

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Other records listing Innovasive Devices, 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.

K994269TITAN RC TACKK993975ABSOLUTE ABSORBABLE INTERFERENCE SCREWK992458RC MULTISUTURE BONE ANCHOR, MODEL 4453/4454K992377RC TACKK990454BIO-INTERFERENCE SCREWK984490SUTURELESS ANCHOR

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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

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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