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FDA 510(k)

ROSETTE KNIFE 4MM

K-Number: K841975 · 1984-06-19

ApplicantStainless Mfg., Inc.
Decision Date1984-06-19
Product CodeHTZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ROSETTE KNIFE 4MM 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 K841975. The device is classified under product code HTZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROSETTE KNIFE 4MM?

ROSETTE KNIFE 4MM 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 K841975.

When did ROSETTE KNIFE 4MM receive FDA 510(k) clearance?

ROSETTE KNIFE 4MM received FDA 510(k) clearance on 1984-06-19, under 510(k) number K841975.

Who is the listed applicant for ROSETTE KNIFE 4MM?

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 ROSETTE KNIFE 4MM?

The FDA product code for ROSETTE KNIFE 4MM is HTZ.

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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 BLADEK8419814MM & 5MM FILEK8419712.5MM & 4MM PROBE K841969-LABELINGK841970CAMELBACK HANDLE-K841969-LABELINGK8419775MM DOUGLE EDGE RING CURETTEK841974RETROGRADE KNIFE 4MM & 5MM

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Related Devices (Code: HTZ)

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.

K933933CEBOPLANESynvasive Technology, Inc.K931737HEDLEYL INTRAMEDULLARY PREPARATION BRUSHSynvasive Technology, Inc.K87088245 DEGREE SHAVERBowen & Company, Inc.K853678KAMBIN SPINAL INSTRUMENT SETPilling Co.K850527ARTHROSCOPY SUCTION BIOPSY PUNCHT. Korossurgical Instruments Corp.K850423CONCEPT SUCTION SLEEVEConcept, 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.

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