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)

MICRO-AIRE STERNUM SAW 4800

K-Number: K894301 · 1989-08-03

ApplicantMicro Surgical Instruments Corp.
Decision Date1989-08-03
Product CodeKFK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MICRO-AIRE STERNUM SAW 4800 is the device name listed in this FDA 510(k) record. The listed applicant is Micro Surgical Instruments Corp.. It received FDA 510(k) clearance on 1989-08-03 under 510(k) number K894301. The device is classified under product code KFK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICRO-AIRE STERNUM SAW 4800?

MICRO-AIRE STERNUM SAW 4800 is a medical device that received FDA 510(k) clearance on 1989-08-03. The listed applicant is Micro Surgical Instruments Corp.. The 510(k) number is K894301.

When did MICRO-AIRE STERNUM SAW 4800 receive FDA 510(k) clearance?

MICRO-AIRE STERNUM SAW 4800 received FDA 510(k) clearance on 1989-08-03, under 510(k) number K894301.

Who is the listed applicant for MICRO-AIRE STERNUM SAW 4800?

The FDA 510(k) record lists Micro Surgical Instruments Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICRO-AIRE STERNUM SAW 4800?

The FDA product code for MICRO-AIRE STERNUM SAW 4800 is KFK.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Micro Surgical Instruments Corp. 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.

K931395SERIES 5000 BATTERY POWERED INSTRUMENT SYSTEMK932492IMPLANTOLOGY MODULE, MODEL 2175K930205ELECTRIC WIRE DRIVER, MODEL 2640EK914998MICROAIRE(R) FACIAL BONE PLATING SYSTEMK915139MODEL 2250-000 ZIMMER STYLE SAGITTAL SAW MODULEK914346DRILL MODULES MODELS 2116/2117

View all 15 devices →

Related Devices (Code: KFK)

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.

K893949#157 EXAM LIGHTMedmark, Inc.K870157OSCILLATING SAW/ RECIPROCATING SAW/ DRILL-REAMERMicro-Aire Surgical Instruments, Inc.K801737STERNUM SAWAmsco Co.

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.

↑