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)

SURGICAL BLADES & SCAPELS (SMPL. W/510K)

K-Number: K812516 · 1981-10-02

ApplicantNeedle Industries(Usa), Inc.
Decision Date1981-10-02
Product CodeGES
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL BLADES & SCAPELS (SMPL. W/510K) is the device name listed in this FDA 510(k) record. The listed applicant is Needle Industries(Usa), Inc.. It received FDA 510(k) clearance on 1981-10-02 under 510(k) number K812516. 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 SURGICAL BLADES & SCAPELS (SMPL. W/510K)?

SURGICAL BLADES & SCAPELS (SMPL. W/510K) is a medical device that received FDA 510(k) clearance on 1981-10-02. The listed applicant is Needle Industries(Usa), Inc.. The 510(k) number is K812516.

When did SURGICAL BLADES & SCAPELS (SMPL. W/510K) receive FDA 510(k) clearance?

SURGICAL BLADES & SCAPELS (SMPL. W/510K) received FDA 510(k) clearance on 1981-10-02, under 510(k) number K812516.

Who is the listed applicant for SURGICAL BLADES & SCAPELS (SMPL. W/510K)?

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

What is the FDA product code for SURGICAL BLADES & SCAPELS (SMPL. W/510K)?

The FDA product code for SURGICAL BLADES & SCAPELS (SMPL. W/510K) 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 Needle Industries(Usa), 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.

K813256HYPODERMIC & SUTURE NEEDLES

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.

↑