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FDA 510(k)

COATED SUTURE NEEDLE

K-Number: K863595 · 1986-10-24

ApplicantSharpoint, Inc.
Decision Date1986-10-24
Product CodeGAB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COATED SUTURE NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Sharpoint, Inc.. It received FDA 510(k) clearance on 1986-10-24 under 510(k) number K863595. The device is classified under product code GAB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COATED SUTURE NEEDLE?

COATED SUTURE NEEDLE is a medical device that received FDA 510(k) clearance on 1986-10-24. The listed applicant is Sharpoint, Inc.. The 510(k) number is K863595.

When did COATED SUTURE NEEDLE receive FDA 510(k) clearance?

COATED SUTURE NEEDLE received FDA 510(k) clearance on 1986-10-24, under 510(k) number K863595.

Who is the listed applicant for COATED SUTURE NEEDLE?

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 COATED SUTURE NEEDLE?

The FDA product code for COATED SUTURE NEEDLE is GAB.

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 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.

K861947SURGICAL KNIFEK840764EAR KNIVESK840855CORNEAL SCLERAL LANCEK840659ANTERIOR CAPSULECTOMY CYSTITOMEK840660POSTERIOR CAPSULOTOMY CYSTITOMEK830522STAINLESS STEEL SUTURE 316L

View all 9 devices →

Related Devices (Code: GAB)

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.

K012199DIGICAPHumana USA, Inc.K980988AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(ASLS)Axya Medical, Inc.K932591ENDO-JUDGESynergistic Medical Technologies, Inc.K895681CONTRAST BACKGROUND MATERIALApplied Medical TechnologiesK831648ANCHOR BRAND SURGICAL NEEDLESAnchor Products Co.K812444RADIATION STERILIZATION FOR NEEDLE CNTRDevon Industries, 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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