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FDA 510(k)

AXICUT DISPOSABLE SCALPEL

K-Number: K811707 · 1981-07-20

ApplicantNeonatal Corp.
Decision Date1981-07-20
Product CodeGDX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AXICUT DISPOSABLE SCALPEL is the device name listed in this FDA 510(k) record. The listed applicant is Neonatal Corp.. It received FDA 510(k) clearance on 1981-07-20 under 510(k) number K811707. 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 AXICUT DISPOSABLE SCALPEL?

AXICUT DISPOSABLE SCALPEL is a medical device that received FDA 510(k) clearance on 1981-07-20. The listed applicant is Neonatal Corp.. The 510(k) number is K811707.

When did AXICUT DISPOSABLE SCALPEL receive FDA 510(k) clearance?

AXICUT DISPOSABLE SCALPEL received FDA 510(k) clearance on 1981-07-20, under 510(k) number K811707.

Who is the listed applicant for AXICUT DISPOSABLE SCALPEL?

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

What is the FDA product code for AXICUT DISPOSABLE SCALPEL?

The FDA product code for AXICUT DISPOSABLE SCALPEL is GDX.

Related Clinical Trials

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Other records listing Neonatal Corp. 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.

K811364AXICARE BREAST SHELLK811403AXICARE BREAST PUMP MODEL

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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