FDA 510(k)

TBW

K-Number: K010545 · 2001-06-06

Decision Date2001-06-06

Product CodeNDL

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

TBW is the device name listed in this FDA 510(k) record. The listed applicant is Tri-Med, Inc.. It received FDA 510(k) clearance on 2001-06-06 under 510(k) number K010545. The device is classified under product code NDL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TBW?

TBW is a medical device that received FDA 510(k) clearance on 2001-06-06. The listed applicant is Tri-Med, Inc.. The 510(k) number is K010545.

When did TBW receive FDA 510(k) clearance?

TBW received FDA 510(k) clearance on 2001-06-06, under 510(k) number K010545.

Who is the listed applicant for TBW?

The FDA 510(k) record lists Tri-Med, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TBW?

The FDA product code for TBW is NDL.

Other records listing Tri-Med, 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.

K040112TRIMED BEARING PLATE; TRIMED VOLAR BEARING PLATE K030877TRIMED RADIAL BULLET K961863PARACENTESIS TRAYS K875224HUDSON CRANINAL BURRS K850747TRI-MED MODEL 105 SPECIAL AIRWAY ADAPTOR K850746TRI-MED MODEL 126 SAMPLE LINE W/EXTENDED LIFE NAFI

View all 29 devices →

Related Devices (Code: NDL)

K010847K'FIXAvanta Orthopaedics, 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.