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FDA 510(k)

MICRO CISE DIAMOND SCALPEL

K-Number: K820730 · 1982-04-09

ApplicantCooperVision, Inc.
Decision Date1982-04-09
Product CodeGDX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MICRO CISE DIAMOND SCALPEL is the device name listed in this FDA 510(k) record. The listed applicant is CooperVision, Inc.. It received FDA 510(k) clearance on 1982-04-09 under 510(k) number K820730. The device is classified under product code GDX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICRO CISE DIAMOND SCALPEL?

MICRO CISE DIAMOND SCALPEL is a medical device that received FDA 510(k) clearance on 1982-04-09. The listed applicant is CooperVision, Inc.. The 510(k) number is K820730.

When did MICRO CISE DIAMOND SCALPEL receive FDA 510(k) clearance?

MICRO CISE DIAMOND SCALPEL received FDA 510(k) clearance on 1982-04-09, under 510(k) number K820730.

Who is the listed applicant for MICRO CISE DIAMOND SCALPEL?

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

What is the FDA product code for MICRO CISE DIAMOND SCALPEL?

The FDA product code for MICRO CISE DIAMOND SCALPEL is GDX.

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Related Devices (Code: GDX)

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.

K923689SURGISTAR BLADESSurgistar, Inc.K921167ULTRABLADEMicron Technology, Inc.K914086ICAN CYLINDRICAL SPONGESIcn Pharmaceuticals, Inc.K904505CCI CORNEAL SCARIFIERBuckman Co., Inc.K9053801-CUT ACL GRAFT KNIFEDepuy, Inc.K895682VESSEL LOOPSApplied Medical Technologies

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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