510(k) Report

FDA applicant

Erbe USA, Inc.

Marietta, GA39 decisions1994–20223 recalls

FDA records 39 decisions for Erbe USA, Inc. (Marietta, GA) from 1994 to 2022: 39 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and OCX (Endoscopic Irrigation/Suction System). Since 2016 its 510(k)s took a median of 60 days from receipt to decision, against 84 for FDA’s reviews in the same codes and years. Its devices cite 55 predicates, 37 of them its own earlier devices. 3 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Erbe USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2007: 22008: 22009: 12010: 22011: 12013: 22014: 12015: 22016: 12018: 12019: 22022: 1
2007high 2 (2007) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

3in 2026

2026 (partial year): 3
2007high 3 (2026) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Erbe USA, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Erbe USA, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories25decisions
  • OCXEndoscopic Irrigation/Suction System6decisions
  • FEQPump, Air, Non-Manual, For Endoscope3decisions
  • FQHLavage, Jet3decisions
  • GEHUnit, Cryosurgical, Accessories2decisions

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 60 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 84 days; 2 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 55 predicates; 37 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 104 times; 37 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K963189Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma Coagulator and AccessoriesErbe USA, Inc. · 199610cite it
  • K083452Erbe Model Vio 300 D with AccessoriesErbe USA, Inc. · 200810cite it
  • K023886Erbe Vio Esu with Accessories, Model Vio 300 DErbe USA, Inc. · 20029cite it
  • K060484Erbe Vio Esu, Model Vio 300 DErbe USA, Inc. · 20069cite it
  • K933157Erbotom Icc 200Erbe USA, Inc. · 19948cite it
  • K024047Erbe Vio Apc with AccessoriesErbe USA, Inc. · 20038cite it

What has FDA decided for it lately?

  • K221177Erbe's Tubing/Cap SetsErbe USA, Inc. · 20221 recall
  • K191438ERBEFLO 2 Endo Quick Connect Pentax Scope Port ConnectorErbe USA, Inc. · 2019
  • K190469ERBEFLO 2 Disposable Tubing SystemErbe USA, Inc. · 20191 recall
  • K182444ERBEFLO Olympus Scope Port ConnectorErbe USA, Inc. · 2018
  • K162152Erbe’s CO2 Tubing/Cap SetsErbe USA, Inc. · 20161 recall
  • K143306ERBE WaterJet Model ERBEJET® 2 System with HybridAPC ProbeErbe USA, Inc. · 2015
  • K151041ERBECRYO 2 Cryosurgical Unit with accessoriesErbe USA, Inc. · 2015
  • K143186Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope Port ConnectorErbe USA, Inc. · 2014

All 39 as Erbe USA, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K221177ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO…Mar 31, 2026Class II
  • K162152ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources, REF…Mar 31, 2026Class II
  • K190469ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222Mar 31, 2026Class II

Other applicant names beginning “Erbe”

FDA records each applicant name separately; these may or may not be the same firm.

Erbe Elektromedizin GmbH 16Erbe Electromedizin GmbH 2