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FDA 510(k)

SCALPEL

K-Number: K780998 · 1978-07-27

ApplicantIsolab, Inc.
Decision Date1978-07-27
Product CodeGDX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SCALPEL is the device name listed in this FDA 510(k) record. The listed applicant is Isolab, Inc.. It received FDA 510(k) clearance on 1978-07-27 under 510(k) number K780998. 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 SCALPEL?

SCALPEL is a medical device that received FDA 510(k) clearance on 1978-07-27. The listed applicant is Isolab, Inc.. The 510(k) number is K780998.

When did SCALPEL receive FDA 510(k) clearance?

SCALPEL received FDA 510(k) clearance on 1978-07-27, under 510(k) number K780998.

Who is the listed applicant for SCALPEL?

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

What is the FDA product code for SCALPEL?

The FDA product code for SCALPEL is GDX.

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Other records listing Isolab, Inc. as applicant

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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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