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FDA 510(k)

6.5MM HEX HANDLE

K-Number: K841969 · 1984-06-19

ApplicantStainless Mfg., Inc.
Decision Date1984-06-19
Product CodeLXH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

6.5MM HEX HANDLE is the device name listed in this FDA 510(k) record. The listed applicant is Stainless Mfg., Inc.. It received FDA 510(k) clearance on 1984-06-19 under 510(k) number K841969. 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 6.5MM HEX HANDLE?

6.5MM HEX HANDLE is a medical device that received FDA 510(k) clearance on 1984-06-19. The listed applicant is Stainless Mfg., Inc.. The 510(k) number is K841969.

When did 6.5MM HEX HANDLE receive FDA 510(k) clearance?

6.5MM HEX HANDLE received FDA 510(k) clearance on 1984-06-19, under 510(k) number K841969.

Who is the listed applicant for 6.5MM HEX HANDLE?

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

What is the FDA product code for 6.5MM HEX HANDLE?

The FDA product code for 6.5MM HEX HANDLE is LXH.

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Other records listing Stainless Mfg., 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.

K841980SIDE CUTTING SERRATED BLADEK8419775MM DOUGLE EDGE RING CURETTEK8419712.5MM & 4MM PROBE K841969-LABELINGK841975ROSETTE KNIFE 4MMK841970CAMELBACK HANDLE-K841969-LABELINGK8419814MM & 5MM FILE

View all 19 devices →

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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