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FDA 510(k)

GHI WET PENCIL

K-Number: K861614 · 1986-07-08

ApplicantSurgical Products Corp.
Decision Date1986-07-08
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GHI WET PENCIL is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Products Corp.. It received FDA 510(k) clearance on 1986-07-08 under 510(k) number K861614. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GHI WET PENCIL?

GHI WET PENCIL is a medical device that received FDA 510(k) clearance on 1986-07-08. The listed applicant is Surgical Products Corp.. The 510(k) number is K861614.

When did GHI WET PENCIL receive FDA 510(k) clearance?

GHI WET PENCIL received FDA 510(k) clearance on 1986-07-08, under 510(k) number K861614.

Who is the listed applicant for GHI WET PENCIL?

The FDA 510(k) record lists Surgical Products Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GHI WET PENCIL?

The FDA product code for GHI WET PENCIL is GEI.

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 Surgical Products Corp. 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.

K921671SURGILASE FIBERLASE VCO2 LASER WAVEGUIDEK841241ANTERIOR CRUCIATE LIGAMENT GRASPERK841247SPC DISPOSABLE CUTTERK841328SPC ARTHROSCOPY TABLEK834434MACH I ELECTROSURGERY HAND CONTROL

Related Devices (Code: GEI)

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.

K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)Stryker InstrumentsK254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLCK261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLCK254185Potenza PrimeJeisys Medical IncorporatedK262364Ellian Enigma RF DeviceEllian CorpK253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.

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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