FDA 510(k)

Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps

K-Number: K203277 · 2021-04-28

Decision Date2021-04-28

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Winter & Ibe GmbH. It received FDA 510(k) clearance on 2021-04-28 under 510(k) number K203277. 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 Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps?

Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps is a medical device that received FDA 510(k) clearance on 2021-04-28. The listed applicant is Olympus Winter & Ibe GmbH. The 510(k) number is K203277.

When did Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps receive FDA 510(k) clearance?

Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps received FDA 510(k) clearance on 2021-04-28, under 510(k) number K203277.

Who is the listed applicant for Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps?

The FDA 510(k) record lists Olympus Winter & Ibe GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps?

The FDA product code for Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps is GEI.

Other records listing Olympus Winter & Ibe GmbH 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.

K260649OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 19.8 Fr. (WA2C19BO); Obturator, 21 Fr. (WA2C21BO); Obturator, 21 Fr., for sheath with ramp (WA2C21RO); Obturator, 21 Fr., long (WA2C21LO); Obturator, 21 Fr., for straight sheath (WA2C21SO); Obturator, 22.5 Fr. (WA2C22BO); Obturator, 25 Fr. (WA2C25BO); Obturator, optical, 19.8 Fr. (WA2C19BV); Obturator, optical, 21 Fr. (WA2C21BV); Obturator, optical, 21 Fr., for straight sheath (WA2C21SV); Obturator, optical,K252043Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211)K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W)K221522HF-cables (resusable)K223183Light-Guide Cables K213207Sheath, Stopcock Accessory

View all 22 devices →

Related Devices (Code: GEI)

K261179AlphaTriPart - Monopolar MIC InstrumentsGimmi GmbH K253504Volnewmer™Classys, Inc.K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS)Olympus Medical Systems Corp.K253484LUTRONIC GENIUSCynosure Lutronic Technology Corporation K251492Irrigation Tubing Bipolar Cord SetNew Deantronics Taiwan , Ltd.K260636Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingStryker Sustainability Solutions

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.