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FDA 510(k)

G.E.V. DISPOSABLE SCALPELS

K-Number: K822893 · 1982-10-22

ApplicantAscep, Inc.
Decision Date1982-10-22
Product CodeGDX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

G.E.V. DISPOSABLE SCALPELS is the device name listed in this FDA 510(k) record. The listed applicant is Ascep, Inc.. It received FDA 510(k) clearance on 1982-10-22 under 510(k) number K822893. 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 G.E.V. DISPOSABLE SCALPELS?

G.E.V. DISPOSABLE SCALPELS is a medical device that received FDA 510(k) clearance on 1982-10-22. The listed applicant is Ascep, Inc.. The 510(k) number is K822893.

When did G.E.V. DISPOSABLE SCALPELS receive FDA 510(k) clearance?

G.E.V. DISPOSABLE SCALPELS received FDA 510(k) clearance on 1982-10-22, under 510(k) number K822893.

Who is the listed applicant for G.E.V. DISPOSABLE SCALPELS?

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

What is the FDA product code for G.E.V. DISPOSABLE SCALPELS?

The FDA product code for G.E.V. DISPOSABLE SCALPELS is GDX.

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Other records listing Ascep, 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.

K830219VARIOUS INSTRUMENTS & INSTRUMENT TRAYSK810004STERILE DISPOSABLE INSTRUMENT TRAYSK802726INSTRUMENTS NONSTERILE & STERILEK791886I.V. CARE KITK791885I.V. START SETK791888CATHETER CARE KIT REORDER 7940&7941

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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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