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FDA 510(k)

SCALPEL BLADE REMOVER (BLADEGARD)

K-Number: K915119 · 1992-05-05

ApplicantIntergrated Visual, Inc.
Decision Date1992-05-05
Product CodeGES
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SCALPEL BLADE REMOVER (BLADEGARD) is the device name listed in this FDA 510(k) record. The listed applicant is Intergrated Visual, Inc.. It received FDA 510(k) clearance on 1992-05-05 under 510(k) number K915119. 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 SCALPEL BLADE REMOVER (BLADEGARD)?

SCALPEL BLADE REMOVER (BLADEGARD) is a medical device that received FDA 510(k) clearance on 1992-05-05. The listed applicant is Intergrated Visual, Inc.. The 510(k) number is K915119.

When did SCALPEL BLADE REMOVER (BLADEGARD) receive FDA 510(k) clearance?

SCALPEL BLADE REMOVER (BLADEGARD) received FDA 510(k) clearance on 1992-05-05, under 510(k) number K915119.

Who is the listed applicant for SCALPEL BLADE REMOVER (BLADEGARD)?

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

What is the FDA product code for SCALPEL BLADE REMOVER (BLADEGARD)?

The FDA product code for SCALPEL BLADE REMOVER (BLADEGARD) is GES.

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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.K911913PRECISION GLIDE - ENHANCED SURGICAL BLADEBd Becton Dickinson Vacutainer Systems PreanalyticK900266STERILE CARBON STEEL SURGICAL BLADERahn LaboratoriesK884862ANCHOR DOUBLE-EDGE MYRINGOTOMY BLADEAnchor Products Co.

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.

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