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FDA 510(k)

P.S.I.-DISPOSABLE SCALPEL SURGEONS HANDLE

K-Number: K863951 · 1986-10-24

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

Device Summary

P.S.I.-DISPOSABLE SCALPEL SURGEONS HANDLE 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 K863951. The device is classified under product code GDZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the P.S.I.-DISPOSABLE SCALPEL SURGEONS HANDLE?

P.S.I.-DISPOSABLE SCALPEL SURGEONS HANDLE 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 K863951.

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

P.S.I.-DISPOSABLE SCALPEL SURGEONS HANDLE received FDA 510(k) clearance on 1986-10-24, under 510(k) number K863951.

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

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 SCALPEL SURGEONS HANDLE?

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

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.

K863950P.S.I.-DISPOSABLE METAL HANDLE SURGEONS SCALPEL

Related Devices (Code: GDZ)

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.

K091462SPECTRA MEDICAL SAFETY SCAPELSpectra, Inc.K890242SCALPEL HANDLEKinetic Medical ProductsK884512BEAVER(R) HANDLEBd Becton Dickinson Vacutainer Systems PreanalyticK863808THE S. CORDERO STYLUSS. Cordero Co.K863212KEISEI HANDLES FOR SURGICAL BLADESKeisei Medical Industrial Co., Ltd.K854858SCALPEL HANDLEMedelec Intl. Corp.

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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