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FDA 510(k)

SURGISMOKE

K-Number: K896822 · 1990-01-11

ApplicantSpectro Industries, Inc.
Decision Date1990-01-11
Product CodeFYD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGISMOKE is the device name listed in this FDA 510(k) record. The listed applicant is Spectro Industries, Inc.. It received FDA 510(k) clearance on 1990-01-11 under 510(k) number K896822. The device is classified under product code FYD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGISMOKE?

SURGISMOKE is a medical device that received FDA 510(k) clearance on 1990-01-11. The listed applicant is Spectro Industries, Inc.. The 510(k) number is K896822.

When did SURGISMOKE receive FDA 510(k) clearance?

SURGISMOKE received FDA 510(k) clearance on 1990-01-11, under 510(k) number K896822.

Who is the listed applicant for SURGISMOKE?

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

What is the FDA product code for SURGISMOKE?

The FDA product code for SURGISMOKE is FYD.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Spectro 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.

K843433KANIEVSKI SENSORY AID OR DEVICE

Related Devices (Code: FYD)

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.

K240127PlumeSafe X5 Smoke Management SystemConmed CorporationK2337898Q10 Surclear Smoke Plume Evacuation SystemSurnic CorporationK213068Medline Smoke Evacuation ShroudMedline Industries, Inc.K202944NEBULAE SRS Laparoscopic Surgical Smoke Removal SystemNorthgate Technologies, Inc.K200250Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF SensorMegadyne Medical Products, Inc.K192035EvaQMax Smoke Evacuation SystemBio Protech, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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