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FDA 510(k)

THE DE SOUTTER M182 DRILL

K-Number: K930785 · 1993-10-27

ApplicantDe Soutter Medical, Ltd.
Decision Date1993-10-27
Product CodeHSZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

THE DE SOUTTER M182 DRILL is the device name listed in this FDA 510(k) record. The listed applicant is De Soutter Medical, Ltd.. It received FDA 510(k) clearance on 1993-10-27 under 510(k) number K930785. The device is classified under product code HSZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE DE SOUTTER M182 DRILL?

THE DE SOUTTER M182 DRILL is a medical device that received FDA 510(k) clearance on 1993-10-27. The listed applicant is De Soutter Medical, Ltd.. The 510(k) number is K930785.

When did THE DE SOUTTER M182 DRILL receive FDA 510(k) clearance?

THE DE SOUTTER M182 DRILL received FDA 510(k) clearance on 1993-10-27, under 510(k) number K930785.

Who is the listed applicant for THE DE SOUTTER M182 DRILL?

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

What is the FDA product code for THE DE SOUTTER M182 DRILL?

The FDA product code for THE DE SOUTTER M182 DRILL is HSZ.

Related Clinical Trials

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Other records listing De Soutter Medical, Ltd. 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.

K930784THE DE SOUTTER M193 REAMER

Related Devices (Code: HSZ)

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.

K991588EMS SWISS ORTHOCLAST(Ems Sa) Electro Medical SystemsK972860CURVTEK TSR SYSTEMBiolectron, Inc.K970345ALIGNMENT INSTRUMENTRichard Wolf Medical Instruments Corp.K955084ASPACH 65,000 (MODIFICATION)The Anspach Effort, Inc.K954080SODEM HIGH SPEED SYSTEMSodem Diffusion SAK944590ETHICON DRILL BIT AND DRILL GUIDEETHICON, Inc.

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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