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FDA 510(k)

BLADE, SURGICAL SCALPEL, STERILE

K-Number: K760361 · 1976-09-13

ApplicantAeroceuticals
Decision Date1976-09-13
Product CodeGES
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BLADE, SURGICAL SCALPEL, STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Aeroceuticals. It received FDA 510(k) clearance on 1976-09-13 under 510(k) number K760361. 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 BLADE, SURGICAL SCALPEL, STERILE?

BLADE, SURGICAL SCALPEL, STERILE is a medical device that received FDA 510(k) clearance on 1976-09-13. The listed applicant is Aeroceuticals. The 510(k) number is K760361.

When did BLADE, SURGICAL SCALPEL, STERILE receive FDA 510(k) clearance?

BLADE, SURGICAL SCALPEL, STERILE received FDA 510(k) clearance on 1976-09-13, under 510(k) number K760361.

Who is the listed applicant for BLADE, SURGICAL SCALPEL, STERILE?

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

What is the FDA product code for BLADE, SURGICAL SCALPEL, STERILE?

The FDA product code for BLADE, SURGICAL SCALPEL, STERILE 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 Aeroceuticals 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.

K770217LANCE LTD. STERI. STITCH CUTTER BLADEK760362LANCET, BLOOD, STERILE STAINLESS STEELK760363SCALPEL, SURGICAL, STERILE STAINLESSK760364HANDLE, SCALPEL, STAINLESS STEEL

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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