Erbe Elektromedizin GmbH: FDA filings under this applicant name

FDA lists 16 510(k) clearances under the applicant name “Erbe Elektromedizin GmbH” (first 1994, latest 2026), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 137 days. Since 2017 the median was 128 days, against 111 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

510(k) clearances per year

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Erbe Elektromedizin GmbH took a median 128 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 111 days.

Top product codes

Review panels

• General and Plastic Surgery (15)
• General Hospital (1)

Most recent Erbe Elektromedizin GmbH 510(k) clearances

6 earlier clearances. See the full list in Caduvo.

Recalls

openFDA lists no recalls under a recalling firm named Erbe Elektromedizin GmbH.

Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

Device clinical trials

An industry sponsor named Erbe Elektromedizin GmbH is the lead sponsor of 6 device studies on ClinicalTrials.gov (3 active or recruiting). Most recent:

• NCT07065214: Argon Plasma Treatment for Ovarian Endometrioma Compared to Standard Cystectomy (Recruiting, started 2025-11-26)
• NCT06249841: Feasibility of Cryobiopsy from the Bile Duct - CRYLEO (Completed, started 2024-03-04)
• NCT06020573: Evaluation of Safety and Performance of Intraoperative Detection of Light Signals During Electrosurgical Breast Cancer Resection (Completed, started 2023-09-26)
• NCT05486338: Endoscopic Gastric Mucosal Ablation as a Primary Obesity Therapy (Active not recruiting, started 2023-09-05)
• NCT05574777: Endoscopic Gastric Mucosal Ablation (GMA) of Class III Obesity (Active not recruiting, started 2023-04-13)

Other FDA applicant names starting with the same word

FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.

• Erbe USA, Inc. (39 510(k)s)
• Erbe Electromedizin GmbH (2 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Erbe Elektromedizin GmbH?

FDA lists 16 510(k) clearances under the applicant name “Erbe Elektromedizin GmbH” (first 1994, latest 2026), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by Erbe Elektromedizin GmbH?

The median time from FDA receipt to decision across 510(k)s cleared under the name Erbe Elektromedizin GmbH is 137 days. Since 2017: 128 days, versus 111 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Erbe Elektromedizin GmbH?

The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 11); GEH (Unit, Cryosurgical, Accessories, 4); FQH (Lavage, Jet, 1).

Next steps

• See all 16 Erbe Elektromedizin GmbH clearances with predicates and recalls
• Run predicate analysis for product code GEI, Erbe Elektromedizin GmbH's most frequent

Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.

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