# K073207: Olympus Esg-100, Model WB991046; Olympus Afu-100, Model WB950167

- Pathway: 510(k) (Traditional)
- Applicant: Celon AG Medical Instruments
- Decided: May 8, 2008 after 177 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K933002 (1994). 4 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023886: Erbe Vio Esu with Accessories, Model Vio 300 D, Erbe USA, Inc. (2002) Summary page 1.
- K933157: Erbotom Icc 200, Erbe USA, Inc. (1994) Summary page 2.
- K000948: Olympus Endoscopic Flushing Pump Model Ofp-1, Keymed (Medical & Industrial Equipment), Ltd. (2000) Summary page 2.
- (no number) Erbe Eip 2: named in the summary without a submission number

## Most influential descendants
- K113119: Endogator Advantage Irrigation Pump (2012), 2 descendants of its own
- K113265: Genii GI 4000 Electrosugical Generator (2012), 1 descendant of its own
- K100899: Olympus Endoscopic Flushing Pump, Model Opf-2 (2010), 1 descendant of its own
- K250657: gi2000 Electrosurgical Generator (2025), 0 descendants of its own
- K241704: Endoscopic Water Pump (2025), 0 descendants of its own

## Recalls of this device
- Nov 28, 2011 · Not classified · Z-0747-2012: Investigations of customer complaints revealed a counterfeit capacitor was used in the manufacture of some lots of the ESG-100.

## Indications for use
The Olympus Electrosurgical System is an electrosurgical system consisting of the Olympus ESG-100 electrosurgical generator, in conjunction with the footswitch and the peristaltic flushing pump Olympus AFU-100. The Olympus ESG-100 is designed to perform monopolar and bipolar functions in the operating arena. The AFU-100 flushing pump is intended for irrigation of instruments or irrigation/flushing/cleansing of tissue surfaces and wounds supporting endoscopic diagnosis or therapy.

Source page: https://510kreport.com/device/K073207
Methodology: https://510kreport.com/methodology