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FDA 510(k)

DISP. MICROSURGICAL KNIVES

K-Number: K821737 · 1982-07-02

ApplicantCoburn Optical Ind., Inc.
Decision Date1982-07-02
Product CodeGES
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DISP. MICROSURGICAL KNIVES is the device name listed in this FDA 510(k) record. The listed applicant is Coburn Optical Ind., Inc.. It received FDA 510(k) clearance on 1982-07-02 under 510(k) number K821737. 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 DISP. MICROSURGICAL KNIVES?

DISP. MICROSURGICAL KNIVES is a medical device that received FDA 510(k) clearance on 1982-07-02. The listed applicant is Coburn Optical Ind., Inc.. The 510(k) number is K821737.

When did DISP. MICROSURGICAL KNIVES receive FDA 510(k) clearance?

DISP. MICROSURGICAL KNIVES received FDA 510(k) clearance on 1982-07-02, under 510(k) number K821737.

Who is the listed applicant for DISP. MICROSURGICAL KNIVES?

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

What is the FDA product code for DISP. MICROSURGICAL KNIVES?

The FDA product code for DISP. MICROSURGICAL KNIVES is GES.

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Other records listing Coburn Optical Ind., 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.

K892347MAGNILINK SYSTEM 101K892349MAGNILINK SYSTEM 209K892351MAGNILINK SYSTEM 602K892348MAGNILINK SYSTEM 201K892350MAGNILINK SYSTEM 402/5K862188IRRIGATION & ASPIRATION/VITRECTOMY DEVICE

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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

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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