The Denver Cautery

Q: When was The Denver Cautery cleared by the FDA?

The Denver Cautery (K922062) received a 510(k) decision of Substantially Equivalent on January 12, 1993, 253 days after the submission was received.

Q: What is the product code of K922062?

The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.

FDA 510(k) K922062 · Denver Splint Co.

Substantially Equivalent

510(k) numberK922062

Submission

Device name: The Denver Cautery
Applicant: Denver Splint Co.
Englewood, CO, US
Received: May 4, 1992
Decision date: January 12, 1993
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: GEI – Electrosurgical, Cutting & Coagulation & Accessories
Device class: Class II (moderate risk)
Regulation: 21 CFR 878.4400
Specialty: General, Plastic Surgery

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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K253859	Scarlet Pro (Scarlet Pro)GEI · Traditional	VIOL Co., Ltd.	08/27/2026SE
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K261179	AlphaTriPart - Monopolar MIC InstrumentsGEI · Traditional	Gimmi GmbH	07/22/2026SE
K253504	VolnewmerGEI · Traditional	Classys, Inc.	07/13/2026SE
K254056	THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…GEI · Traditional	Olympus Medical Systems Corp.	07/01/2026SE
K253484	Lutronic GeniusGEI · Traditional	Cynosure Lutronic Technology Corporation	06/29/2026SE
K251492	Irrigation Tubing Bipolar Cord SetGEI · Traditional	New Deantronics Taiwan , Ltd.	06/29/2026SE
K260636	Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingGEI · Traditional	Stryker Sustainability Solutions	06/18/2026SE

510(k)	Device	Decision
K940798	Shippert Pressure BandageKGX · Traditional	09/28/1994SE
K940133	The Expandacell Ear PackLRD · Traditional	05/23/1994SE
K935724	The Expandacell Sinus PackEMX · Traditional	05/12/1994SE

Questions and answers

When was The Denver Cautery cleared by the FDA?

The Denver Cautery (K922062) received a 510(k) decision of Substantially Equivalent on January 12, 1993, 253 days after the submission was received.

What is the product code of K922062?

The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.