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FDA 510(k)

P.S.I.-DISPOSABLE METAL HANDLE SURGEONS SCALPEL

K-Number: K863950 · 1986-10-24

ApplicantPrecision Surgical Industries, Inc.
Decision Date1986-10-24
Product CodeGDX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

P.S.I.-DISPOSABLE METAL HANDLE SURGEONS SCALPEL is the device name listed in this FDA 510(k) record. The listed applicant is Precision Surgical Industries, Inc.. It received FDA 510(k) clearance on 1986-10-24 under 510(k) number K863950. 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 P.S.I.-DISPOSABLE METAL HANDLE SURGEONS SCALPEL?

P.S.I.-DISPOSABLE METAL HANDLE SURGEONS SCALPEL is a medical device that received FDA 510(k) clearance on 1986-10-24. The listed applicant is Precision Surgical Industries, Inc.. The 510(k) number is K863950.

When did P.S.I.-DISPOSABLE METAL HANDLE SURGEONS SCALPEL receive FDA 510(k) clearance?

P.S.I.-DISPOSABLE METAL HANDLE SURGEONS SCALPEL received FDA 510(k) clearance on 1986-10-24, under 510(k) number K863950.

Who is the listed applicant for P.S.I.-DISPOSABLE METAL HANDLE SURGEONS SCALPEL?

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

What is the FDA product code for P.S.I.-DISPOSABLE METAL HANDLE SURGEONS SCALPEL?

The FDA product code for P.S.I.-DISPOSABLE METAL HANDLE SURGEONS SCALPEL is GDX.

Related Clinical Trials

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.

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Other records listing Precision Surgical Industries, 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.

K863951P.S.I.-DISPOSABLE SCALPEL SURGEONS HANDLE

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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