FDA 510(k)

SURE-CUT

K-Number: K833467 · 1984-01-27

Decision Date1984-01-27

Product CodeGDX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

SURE-CUT is the device name listed in this FDA 510(k) record. The listed applicant is Diverse Technologies, Inc.. It received FDA 510(k) clearance on 1984-01-27 under 510(k) number K833467. 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 SURE-CUT?

SURE-CUT is a medical device that received FDA 510(k) clearance on 1984-01-27. The listed applicant is Diverse Technologies, Inc.. The 510(k) number is K833467.

When did SURE-CUT receive FDA 510(k) clearance?

SURE-CUT received FDA 510(k) clearance on 1984-01-27, under 510(k) number K833467.

Who is the listed applicant for SURE-CUT?

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

What is the FDA product code for SURE-CUT?

The FDA product code for SURE-CUT is GDX.

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

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