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FDA 510(k)

MODEL 2100 ND:YAG SURGICAL LASER NEUROSURGICAL IND

K-Number: K861044 · 1986-10-28

ApplicantSharplan Industries, Inc.
Decision Date1986-10-28
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODEL 2100 ND:YAG SURGICAL LASER NEUROSURGICAL IND is the device name listed in this FDA 510(k) record. The listed applicant is Sharplan Industries, Inc.. It received FDA 510(k) clearance on 1986-10-28 under 510(k) number K861044. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 2100 ND:YAG SURGICAL LASER NEUROSURGICAL IND?

MODEL 2100 ND:YAG SURGICAL LASER NEUROSURGICAL IND is a medical device that received FDA 510(k) clearance on 1986-10-28. The listed applicant is Sharplan Industries, Inc.. The 510(k) number is K861044.

When did MODEL 2100 ND:YAG SURGICAL LASER NEUROSURGICAL IND receive FDA 510(k) clearance?

MODEL 2100 ND:YAG SURGICAL LASER NEUROSURGICAL IND received FDA 510(k) clearance on 1986-10-28, under 510(k) number K861044.

Who is the listed applicant for MODEL 2100 ND:YAG SURGICAL LASER NEUROSURGICAL IND?

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

What is the FDA product code for MODEL 2100 ND:YAG SURGICAL LASER NEUROSURGICAL IND?

The FDA product code for MODEL 2100 ND:YAG SURGICAL LASER NEUROSURGICAL IND is GEX. This falls under the Gastroenterology category.

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Other records listing Sharplan 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.

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Official Source

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