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FDA 510(k)

SWISS LITHOCLAST MASTER HANDPIECE AND 3.2 MM PROBE

K-Number: K974164 · 1997-12-18

ApplicantMedical Device Consultants, Inc.
Decision Date1997-12-18
Product CodeFFK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SWISS LITHOCLAST MASTER HANDPIECE AND 3.2 MM PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Medical Device Consultants, Inc.. It received FDA 510(k) clearance on 1997-12-18 under 510(k) number K974164. The device is classified under product code FFK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SWISS LITHOCLAST MASTER HANDPIECE AND 3.2 MM PROBE?

SWISS LITHOCLAST MASTER HANDPIECE AND 3.2 MM PROBE is a medical device that received FDA 510(k) clearance on 1997-12-18. The listed applicant is Medical Device Consultants, Inc.. The 510(k) number is K974164.

When did SWISS LITHOCLAST MASTER HANDPIECE AND 3.2 MM PROBE receive FDA 510(k) clearance?

SWISS LITHOCLAST MASTER HANDPIECE AND 3.2 MM PROBE received FDA 510(k) clearance on 1997-12-18, under 510(k) number K974164.

Who is the listed applicant for SWISS LITHOCLAST MASTER HANDPIECE AND 3.2 MM PROBE?

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

What is the FDA product code for SWISS LITHOCLAST MASTER HANDPIECE AND 3.2 MM PROBE?

The FDA product code for SWISS LITHOCLAST MASTER HANDPIECE AND 3.2 MM PROBE is FFK.

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Related Devices (Code: FFK)

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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