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FDA 510(k)

TENSIOMETER

K-Number: K883694 · 1988-11-22

ApplicantW. L. Gore & Associates, Inc.
Decision Date1988-11-22
Product CodeLXH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TENSIOMETER is the device name listed in this FDA 510(k) record. The listed applicant is W. L. Gore & Associates, Inc.. It received FDA 510(k) clearance on 1988-11-22 under 510(k) number K883694. The device is classified under product code LXH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TENSIOMETER?

TENSIOMETER is a medical device that received FDA 510(k) clearance on 1988-11-22. The listed applicant is W. L. Gore & Associates, Inc.. The 510(k) number is K883694.

When did TENSIOMETER receive FDA 510(k) clearance?

TENSIOMETER received FDA 510(k) clearance on 1988-11-22, under 510(k) number K883694.

Who is the listed applicant for TENSIOMETER?

The FDA 510(k) record lists W. L. Gore & Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TENSIOMETER?

The FDA product code for TENSIOMETER is LXH.

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Other records listing W. L. Gore & Associates, 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.

K250410GORE® Tri-Lobe Balloon CatheterK240083GORE® PROPATEN® Vascular GraftK232312GORE® PROPATEN® Vascular GraftK233551GORE® ACUSEAL Vascular GraftK231505GORE® ACUSEAL Vascular GraftK222919GORE® ENFORM Biomaterial

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Related Devices (Code: LXH)

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.

K192873SX-One MicroKnifeSonex Health, Inc.K101609SELF RETAINING SOFT TISSUE RETRACTORKoros USA, Inc.K001507MICROPERFORATION INSTRUMENTSmith & Nephew, Inc.K952495ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEMOrthopedic Systems, Inc.K943873ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SYOrthomet, Inc.K944188SPINAL MARKERLeibinger L.P.

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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