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FDA 510(k)

LAPAROSCOPY SET

K-Number: K924485 · 1994-03-09

ApplicantOwens Precision Systems, Inc.
Decision Date1994-03-09
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LAPAROSCOPY SET is the device name listed in this FDA 510(k) record. The listed applicant is Owens Precision Systems, Inc.. It received FDA 510(k) clearance on 1994-03-09 under 510(k) number K924485. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAPAROSCOPY SET?

LAPAROSCOPY SET is a medical device that received FDA 510(k) clearance on 1994-03-09. The listed applicant is Owens Precision Systems, Inc.. The 510(k) number is K924485.

When did LAPAROSCOPY SET receive FDA 510(k) clearance?

LAPAROSCOPY SET received FDA 510(k) clearance on 1994-03-09, under 510(k) number K924485.

Who is the listed applicant for LAPAROSCOPY SET?

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

What is the FDA product code for LAPAROSCOPY SET?

The FDA product code for LAPAROSCOPY SET is HET.

Related Clinical Trials

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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Other records listing Owens Precision Systems, 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.

K944055FORCEPS, SURGICAL GYNECOLOGICALK924224OWENS BIOPSY FORCEPS

Related Devices (Code: HET)

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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