Hot Biopsy Forceps

FDA 510(k) K905088 · Esco Precision, Inc.

Substantially Equivalent

510(k) numberK905088

Submission

Device name
Hot Biopsy Forceps
Applicant
Esco Precision, Inc.
Stony Brook, NY, US
Received
November 14, 1990
Decision date
March 19, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KGE – Forceps, Biopsy, Electric
Device class
Class II (moderate risk)
Regulation
21 CFR 876.4300
Specialty
Gastroenterology, Urology

Other 510(k)s with product code KGE

510(k)DeviceApplicantDecision
K251807Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LRKGE · Traditional Olympus Medical Systems Corp.03/06/2026SE
K250187Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U)KGE · Traditional Olympus Medical Systems Corporation10/07/2025SE
K242857ClearHemograsperKGE · Traditional Finemedix Co., Ltd.05/21/2025SE
K231721Disposable Hot Biopsy ForcepsKGE · Traditional Beijing Zksk Technology Co., Ltd.12/14/2023SE
K220053Diathermic Slitter (FlushKnife) DK2620JI and DK2623JIKGE · Special Fujifilm Corporation02/04/2022SE
K210406Bipolar Coagulation ForecepsKGE · Traditional Hangzhou AGS MedTech Co., Ltd.10/05/2021SE
K202438Ensure Single-Use Coagulation ForcepsKGE · Traditional Micro-Tech (Nanjing) Co., Ltd.03/15/2021SE
K183428Avulsion ForcepsKGE · Traditional STERIS Corporation04/16/2019SE
K180018Disposable Hot Biopsy ForcepsKGE · Traditional Micro-Tech (Nanjing) Co., Ltd.07/05/2018SE
K180134Ensizor Monopolar Endoscopic ScissorsKGE · Traditional Slater Endoscopy, LLC06/29/2018SE

More from Slater Endoscopy, LLC

510(k)DeviceDecision
K900065Non-Electric Biopsy ForcepsFCL · Traditional 03/15/1990SE
K900015Non-Electric Biopsy ForcepsFCL · Traditional 03/15/1990SE

Questions and answers

When was Hot Biopsy Forceps cleared by the FDA?

Hot Biopsy Forceps (K905088) received a 510(k) decision of Substantially Equivalent on March 19, 1991, 125 days after the submission was received.

What is the product code of K905088?

The FDA product code is KGE – Forceps, Biopsy, Electric, a Class II (moderate risk) device regulated under 21 CFR 876.4300.