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FDA 510(k)

OPUS MAGNUM ANCHOR & INSERTER

K-Number: K012125 · 2001-09-17

ApplicantOpus Medical, Inc.
Decision Date2001-09-17
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OPUS MAGNUM ANCHOR & INSERTER is the device name listed in this FDA 510(k) record. The listed applicant is Opus Medical, Inc.. It received FDA 510(k) clearance on 2001-09-17 under 510(k) number K012125. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPUS MAGNUM ANCHOR & INSERTER?

OPUS MAGNUM ANCHOR & INSERTER is a medical device that received FDA 510(k) clearance on 2001-09-17. The listed applicant is Opus Medical, Inc.. The 510(k) number is K012125.

When did OPUS MAGNUM ANCHOR & INSERTER receive FDA 510(k) clearance?

OPUS MAGNUM ANCHOR & INSERTER received FDA 510(k) clearance on 2001-09-17, under 510(k) number K012125.

Who is the listed applicant for OPUS MAGNUM ANCHOR & INSERTER?

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

What is the FDA product code for OPUS MAGNUM ANCHOR & INSERTER?

The FDA product code for OPUS MAGNUM ANCHOR & INSERTER is HTY.

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Other records listing Opus Medical, 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.

K042584OPUS MINIMAGNUM ANCHOR WITH INSERTERK042914OPUS MAGNUM KNOTLESS ANCHOR WITH INSERTER HANDLEK042031OPUS SPEEDSTITCH SUTURE DEVICEK041440OPUS MAGNUM ANCHOR WITH INSERTERK033317SMARTSTITCH M-CONNECTOR, MODEL OM-8700; NEEDLE CASSETTE, OM-8750; AUTOCUFF SYSTEM INSTRUMENT SET, OM-9070K030170REUSABLE SMARTSTITCH SUTURE DEVICE, MODELS OM-8007, OM-8500

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Related Devices (Code: HTY)

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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