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)

SURGI-BRUSH

K-Number: K896085 · 1989-11-08

ApplicantSparta Surgical Corp.
Decision Date1989-11-08
Product CodeGEC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGI-BRUSH is the device name listed in this FDA 510(k) record. The listed applicant is Sparta Surgical Corp.. It received FDA 510(k) clearance on 1989-11-08 under 510(k) number K896085. The device is classified under product code GEC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGI-BRUSH?

SURGI-BRUSH is a medical device that received FDA 510(k) clearance on 1989-11-08. The listed applicant is Sparta Surgical Corp.. The 510(k) number is K896085.

When did SURGI-BRUSH receive FDA 510(k) clearance?

SURGI-BRUSH received FDA 510(k) clearance on 1989-11-08, under 510(k) number K896085.

Who is the listed applicant for SURGI-BRUSH?

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

What is the FDA product code for SURGI-BRUSH?

The FDA product code for SURGI-BRUSH is GEC.

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 Sparta Surgical 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.

K965187SPECTRUM II, SPECTRUM PLUS, AND SPECTRUM MAX-SDK945313SPARTA HYDROGEL WOUND DRESSINGK922729SPARTA WET DRESSING, SODIUM CHLORIDEK905384DAVID SIMMONDS ANESTHESIA EXTENSION TUBESK905240VESSELOOPSK896084MICROSPEARS

View all 7 devices →

Related Devices (Code: GEC)

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.

K971473IVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCKM-Pact Worldwide Management Corp.K960621EXPANDACELL INSTRUMENT WIPEShippert Medical Technologies Corp.K900691BIODYNE INSTRUMENT WIPESBio-Dyne, Inc.K875033STERILE SCRUBBY SCRUB BRUSHMedsurg Industries, Inc.K875129STERI-CLENSAbsorbent Cotton Co., Inc.K872823DELTA SCRUBPacific Biosystems, 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.

↑