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)

SURGIMED - SURGICAL BLADES

K-Number: K851157 · 1985-04-25

ApplicantSurgimed Corp.
Decision Date1985-04-25
Product CodeGES
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGIMED - SURGICAL BLADES is the device name listed in this FDA 510(k) record. The listed applicant is Surgimed Corp.. It received FDA 510(k) clearance on 1985-04-25 under 510(k) number K851157. The device is classified under product code GES. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGIMED - SURGICAL BLADES?

SURGIMED - SURGICAL BLADES is a medical device that received FDA 510(k) clearance on 1985-04-25. The listed applicant is Surgimed Corp.. The 510(k) number is K851157.

When did SURGIMED - SURGICAL BLADES receive FDA 510(k) clearance?

SURGIMED - SURGICAL BLADES received FDA 510(k) clearance on 1985-04-25, under 510(k) number K851157.

Who is the listed applicant for SURGIMED - SURGICAL BLADES?

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

What is the FDA product code for SURGIMED - SURGICAL BLADES?

The FDA product code for SURGIMED - SURGICAL BLADES is GES.

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 Surgimed 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.

K840762SILVERTORQUE CEREBRAL CATHETERK840763SILVERTORQUE CARDIAC CATHETERSK840761SILVERTORQUE VISCERAL CATHETERK810689BALLOON CATHETER

Related Devices (Code: GES)

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.

K032242PERSONNA PLUS SAFETY SCALPEL SYSTEMOmi Manufacturing Pty., Ltd.K932998EASY-ONDevon Industries, Inc.K923170LOS ALAMOS RETRACTABLE KNIFEInnovative Surgical Technology, Inc.K915119SCALPEL BLADE REMOVER (BLADEGARD)Intergrated Visual, Inc.K911913PRECISION GLIDE - ENHANCED SURGICAL BLADEBd Becton Dickinson Vacutainer Systems PreanalyticK900266STERILE CARBON STEEL SURGICAL BLADERahn Laboratories

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.

↑