Replace-A-Tip Adjustable High Temp.

Q: What is the product code of K841509?

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) K841509 · Suncoast Medical Manufacturers, Inc.

Substantially Equivalent

510(k) numberK841509

Submission

Device name: Replace-A-Tip Adjustable High Temp.
Applicant: Suncoast Medical Manufacturers, Inc.
Mchenry, IL, US
Received: April 11, 1984
Decision date: December 7, 1984
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

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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510(k)	Device	Decision
K841604	Adjust-A-Temp High TemperatureGEI · Traditional	12/07/1984SE
K841603	Adjust-A-Temp MicroGEI · Traditional	12/07/1984SE
K841459	Replace-A-Tip Adjust. Low Temp.-GEI · Traditional	12/07/1984SE
K841591	Pyro-TipGEI · Traditional	10/31/1984SE
K840376	Surg-A Stat Loop TipGEI · Traditional	10/26/1984SE
K840387	Surg-A-Stat Loop Tip 2GEI · Traditional	07/23/1984SE
K840377	Surg-A-Stat Cardiovascular TipGEI · Traditional	07/23/1984SE
K840375	Surg-A-Stat Loop Tip 15GEI · Traditional	07/23/1984SE
K840370	Surg-A-Stat Vasectomy TipGET · Traditional	07/23/1984SE
K841589	C-LiteKYT · Traditional	05/22/1984SE

Questions and answers

When was Replace-A-Tip Adjustable High Temp. cleared by the FDA?

Replace-A-Tip Adjustable High Temp. (K841509) received a 510(k) decision of Substantially Equivalent on December 7, 1984, 240 days after the submission was received.

What is the product code of K841509?

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