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FDA 510(k)

LAPARO-TENSER

K-Number: K970712 · 1998-07-21

Decision Date1998-07-21
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LAPARO-TENSER is the device name listed in this FDA 510(k) record. The listed applicant is L & T S.N.C. DI E. Lucini & C.. It received FDA 510(k) clearance on 1998-07-21 under 510(k) number K970712. 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 LAPARO-TENSER?

LAPARO-TENSER is a medical device that received FDA 510(k) clearance on 1998-07-21. The listed applicant is L & T S.N.C. DI E. Lucini & C.. The 510(k) number is K970712.

When did LAPARO-TENSER receive FDA 510(k) clearance?

LAPARO-TENSER received FDA 510(k) clearance on 1998-07-21, under 510(k) number K970712.

Who is the listed applicant for LAPARO-TENSER?

The FDA 510(k) record lists L & T S.N.C. DI E. Lucini & C. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LAPARO-TENSER?

The FDA product code for LAPARO-TENSER 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.

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.

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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