Effner Cautery Instruments

FDA 510(k) K875260 · Effner and Spreine Co.

Substantially Equivalent

510(k) numberK875260

Submission

Device name
Effner Cautery Instruments
Applicant
Effner and Spreine Co.
Port Washington, NY, US
Received
December 22, 1987
Decision date
June 6, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HQP – Unit, Cautery, Thermal, Battery-Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 886.4115
Specialty
Ophthalmic

Other 510(k)s with product code HQP

510(k)DeviceApplicantDecision
K121441Cautery; Low Temperature (Fineadjustable Fine Tip, Elongated Fine Tip, Micro Fine Tip)HQP · Traditional Bovie Medical Corporation07/20/2012SE
K083428F7244, F7255, F7266, F7277, F7288, F7233, F7234 Series of Battery-Powered CauteryHQP · Traditional Fiab Spa09/01/2009SE
K062659Kirwan Disposable Battery-Powered Cautery, Model 41-61XX SeriesHQP · Traditional Kirwan Surgical Products, Inc.03/09/2007SE
K023506Surgical Medical Device CauteryHQP · Traditional Modern Medical Equipment Mfg., Ltd.01/13/2004SE
K002547Starion Instruments Power Point Cautery Grasper/DissectorHQP · Traditional Starion Instruments10/20/2000SE
K994019Cautery Grasper/DissectorHQP · Traditional Starion Instruments01/20/2000SE
K990728Thermal Cautery Device, ForcepsHQP · Traditional Starion Instruments06/03/1999SE
K952784Oxboro-Medical Cautery Tip CleanerHQP · Traditional Oxboro Medical Intl., Inc.07/13/1995SE
K945761Low Temperature Cautery Fine Tip, Adjustable, Replaceable TipHQP · Traditional Aaron Medical Industries04/10/1995SE
K945763Low Temperature Cautery Elongated Fine TipHQP · Traditional Aaron Medical Industries02/07/1995SE

More from Aaron Medical Industries

510(k)DeviceDecision
K874755Effner Fe-Ex* OrogastricKNT · Traditional 04/06/1988SE
K872480Kahn-Tact U.S.A., Eff LaryngoscopeCCW · Traditional 08/10/1987SE
K852014Effner Sims Rectal Speculum W/Fiber Optic IlluminaKOA · Traditional 08/07/1985SE

Questions and answers

When was Effner Cautery Instruments cleared by the FDA?

Effner Cautery Instruments (K875260) received a 510(k) decision of Substantially Equivalent on June 6, 1988, 167 days after the submission was received.

What is the product code of K875260?

The FDA product code is HQP – Unit, Cautery, Thermal, Battery-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.4115.