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FDA 510(k)

CORNEAL SCLERAL LANCE

K-Number: K840855 · 1984-05-09

ApplicantSharpoint, Inc.
Decision Date1984-05-09
Product CodeHNN
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CORNEAL SCLERAL LANCE is the device name listed in this FDA 510(k) record. The listed applicant is Sharpoint, Inc.. It received FDA 510(k) clearance on 1984-05-09 under 510(k) number K840855. The device is classified under product code HNN. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORNEAL SCLERAL LANCE?

CORNEAL SCLERAL LANCE is a medical device that received FDA 510(k) clearance on 1984-05-09. The listed applicant is Sharpoint, Inc.. The 510(k) number is K840855.

When did CORNEAL SCLERAL LANCE receive FDA 510(k) clearance?

CORNEAL SCLERAL LANCE received FDA 510(k) clearance on 1984-05-09, under 510(k) number K840855.

Who is the listed applicant for CORNEAL SCLERAL LANCE?

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 CORNEAL SCLERAL LANCE?

The FDA product code for CORNEAL SCLERAL LANCE is HNN.

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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 NEEDLEK861947SURGICAL KNIFEK840764EAR KNIVESK840659ANTERIOR CAPSULECTOMY CYSTITOMEK840660POSTERIOR CAPSULOTOMY CYSTITOMEK830522STAINLESS STEEL SUTURE 316L

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Related Devices (Code: HNN)

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.

K110166CLEARCUT S SAFETY KNIFEAlcon Research, Ltd.K922378OPHTHALMIC KNIFEMicroptics Development LaboratoryK882402RETRACTIVE INCISION MICROMETER (RIM) GUAGEOptical CenterK881669MVR/STILETTO BLADE 20GA. - P/N 1900Advanced Surgical Products, Inc.K874979PRISMA DISPOSABLE MVR/STILETTO BLADEAdvanced Surgical Products, Inc.K874057OPHTHALMIC TIP & BLADE SCALPELSMyocure, 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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