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FDA 510(k)

SURGICAL INSTRUMENT

K-Number: K833541 · 1983-11-28

ApplicantHirata Sangyo Co. USA, Inc.
Decision Date1983-11-28
Product CodeGAD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Hirata Sangyo Co. USA, Inc.. It received FDA 510(k) clearance on 1983-11-28 under 510(k) number K833541. The device is classified under product code GAD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICAL INSTRUMENT?

SURGICAL INSTRUMENT is a medical device that received FDA 510(k) clearance on 1983-11-28. The listed applicant is Hirata Sangyo Co. USA, Inc.. The 510(k) number is K833541.

When did SURGICAL INSTRUMENT receive FDA 510(k) clearance?

SURGICAL INSTRUMENT received FDA 510(k) clearance on 1983-11-28, under 510(k) number K833541.

Who is the listed applicant for SURGICAL INSTRUMENT?

The FDA 510(k) record lists Hirata Sangyo Co. USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGICAL INSTRUMENT?

The FDA product code for SURGICAL INSTRUMENT is GAD.

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Related PubMed Literature

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.

PMID: 29602568Evaluation of Ophthalmic Surgical Instrument Sterility Using Short-Cycle Sterilization for Sequential Same-Day Use.Ophthalmology ()

Other records listing Hirata Sangyo Co. USA, 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.

K864106SR-MODEL 230 (MODIFICATION)K842289SR- MODEL 230K833542SURGICAL INSTRUMENTK832686MULTIPLE MANUAL SURGICAL INSTRUMENTSK831583GP-303K821989NON-STETHO 7, UM-15TP

View all 8 devices →

Related Devices (Code: GAD)

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.

K152538JRP Wound SpreaderJ.R. Parker, LLCK151104OTELO LLSpineartK132645THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADESMedtronic, Inc.K071775DASHEzsurgicalK050256APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTORApple Medical Corp.K043602QUADRANT RETRACTOR SYSTEMMedtronic Sofamor Danek

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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