Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

I/A KIT

K-Number: K830859 · 1983-05-02

ApplicantSurgeon Surgical Instrumentation, Inc.
Decision Date1983-05-02
Product CodeGBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

I/A KIT is the device name listed in this FDA 510(k) record. The listed applicant is Surgeon Surgical Instrumentation, Inc.. It received FDA 510(k) clearance on 1983-05-02 under 510(k) number K830859. The device is classified under product code GBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the I/A KIT?

I/A KIT is a medical device that received FDA 510(k) clearance on 1983-05-02. The listed applicant is Surgeon Surgical Instrumentation, Inc.. The 510(k) number is K830859.

When did I/A KIT receive FDA 510(k) clearance?

I/A KIT received FDA 510(k) clearance on 1983-05-02, under 510(k) number K830859.

Who is the listed applicant for I/A KIT?

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

What is the FDA product code for I/A KIT?

The FDA product code for I/A KIT is GBX.

Other records listing Surgeon Surgical Instrumentation, 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.

K954241SURGIN GENISIS PHACOEMULSIFIERK932281VERRES NEEDLEK922038CO2 INSUFFLATION TUBINGK904010SURGICAL ASPIRATOR KITK890447HEMORRHAGE OCCLUDORK880543UNI-PORT

View all 10 devices →

Related Devices (Code: GBX)

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.

K082725GRAFTGUARD PRESSURE CONTROLLING SYRINGEMaquet Cardiovascular, LLCK052286DEUTSCH ANTI-BLOCKAGE WOUND DRAINThe Catheter Exchange, Inc.K043515GRAFTSAVERVescare, Inc.K013417MISONIX IRRIGATION SYSTEM MOEDL BC20PMisonix, Inc.K000704DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS)Dmc Medical, Ltd.K974233LYSONIX IRRIGATION SYSTEMLysonix, 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.

↑