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FDA 510(k)

SURGICAL KNIFE

K-Number: K861947 · 1986-06-06

ApplicantSharpoint, Inc.
Decision Date1986-06-06
Product CodeEMF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL KNIFE is the device name listed in this FDA 510(k) record. The listed applicant is Sharpoint, Inc.. It received FDA 510(k) clearance on 1986-06-06 under 510(k) number K861947. The device is classified under product code EMF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICAL KNIFE?

SURGICAL KNIFE is a medical device that received FDA 510(k) clearance on 1986-06-06. The listed applicant is Sharpoint, Inc.. The 510(k) number is K861947.

When did SURGICAL KNIFE receive FDA 510(k) clearance?

SURGICAL KNIFE received FDA 510(k) clearance on 1986-06-06, under 510(k) number K861947.

Who is the listed applicant for SURGICAL KNIFE?

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

What is the FDA product code for SURGICAL KNIFE?

The FDA product code for SURGICAL KNIFE is EMF.

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Other records listing Sharpoint, 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.

K863595COATED SUTURE NEEDLEK840764EAR KNIVESK840855CORNEAL SCLERAL LANCEK840659ANTERIOR CAPSULECTOMY CYSTITOMEK840660POSTERIOR CAPSULOTOMY CYSTITOMEK830522STAINLESS STEEL SUTURE 316L

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Related Devices (Code: EMF)

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.

K080133MOUNTABLE ENDOSCOPIC BLADEA.M. Surgical, Inc.K982142MOUNTABLE ENDOSCOPIC KNIFEA.M. Surgical, Inc.K890217MICROSURGICAL KNIVESKinetic Medical ProductsK890215MICROSURGICAL SCARIFIERKinetic Medical ProductsK890214MICROSURGERY RAZOR BLADE HOLDERKinetic Medical ProductsK880094VAN-TEC ENDOPYELOTOMY KNIFEVan-Tec, Inc.

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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