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FDA 510(k)

SURGICAL BLADES

K-Number: K854620 · 1985-12-17

ApplicantNiraj Industries
Decision Date1985-12-17
Product CodeGES
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL BLADES is the device name listed in this FDA 510(k) record. The listed applicant is Niraj Industries. It received FDA 510(k) clearance on 1985-12-17 under 510(k) number K854620. 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?

SURGICAL BLADES is a medical device that received FDA 510(k) clearance on 1985-12-17. The listed applicant is Niraj Industries. The 510(k) number is K854620.

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

SURGICAL BLADES received FDA 510(k) clearance on 1985-12-17, under 510(k) number K854620.

Who is the listed applicant for SURGICAL BLADES?

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

What is the FDA product code for SURGICAL BLADES?

The FDA product code for SURGICAL BLADES 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.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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