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)

SURGISTAR BLADES

K-Number: K923689 · 1992-09-09

ApplicantSurgistar, Inc.
Decision Date1992-09-09
Product CodeGDX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGISTAR BLADES is the device name listed in this FDA 510(k) record. The listed applicant is Surgistar, Inc.. It received FDA 510(k) clearance on 1992-09-09 under 510(k) number K923689. The device is classified under product code GDX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGISTAR BLADES?

SURGISTAR BLADES is a medical device that received FDA 510(k) clearance on 1992-09-09. The listed applicant is Surgistar, Inc.. The 510(k) number is K923689.

When did SURGISTAR BLADES receive FDA 510(k) clearance?

SURGISTAR BLADES received FDA 510(k) clearance on 1992-09-09, under 510(k) number K923689.

Who is the listed applicant for SURGISTAR BLADES?

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

What is the FDA product code for SURGISTAR BLADES?

The FDA product code for SURGISTAR BLADES is GDX.

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 Surgistar, 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.

K030891SURGISTAR MICROKERATOME BLADE, MODEL NO. 2400-LSKK992978RICROKERATOME BLADEK941747SURGISTAR TROCARS

Related Devices (Code: GDX)

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.

K921167ULTRABLADEMicron Technology, Inc.K914086ICAN CYLINDRICAL SPONGESIcn Pharmaceuticals, Inc.K904505CCI CORNEAL SCARIFIERBuckman Co., Inc.K9053801-CUT ACL GRAFT KNIFEDepuy, Inc.K895682VESSEL LOOPSApplied Medical TechnologiesK893033MINI-DIAMOND KNIFEL.A.B. Instruments

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.

↑