Karl Storz Endoscopy: FDA filings under this applicant name

FDA lists 35 510(k) clearances under the applicant name “Karl Storz Endoscopy” (first 1995, latest 2005), across 21 product codes in 8 review panels. Median 510(k) review time under this name: 81 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

Caduvo groups this applicant name under KARL STORZ, based on public ownership records.

510(k) clearances per year

Top product codes

Plus 11 more product codes.

Review panels

• General and Plastic Surgery (8)
• Gastroenterology and Urology (7)
• Obstetrics and Gynecology (7)
• Orthopedic (7)
• Ear, Nose and Throat (2)
• Neurology (2)
• General Hospital (1)
• Radiology (1)

Most recent Karl Storz Endoscopy 510(k) clearances

25 earlier clearances. See the full list in Caduvo.

Recalls

71 product recalls in 26 recall events; 52 initiated in the last five years. Most recent: 2026-05-21.

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.

Related HCPCS codes

HCPCS Level II codes whose descriptors match the device names of the product codes filed under Karl Storz Endoscopy (a text match, not an official crosswalk):

• A4220 — Refill kit for implantable infusion pump (via DQI)
• E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via DQI)

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.

• KARL STORZ Endoscopy-America, Inc. (334 510(k)s)
• Karl Storz Endoscopy America, Inc. (30 510(k)s)
• Karl Storz SE & CO. KG (30 510(k)s)
• Karl Storz Endoskop GmbH (11 510(k)s)
• Karl Storz Imaging, Inc. (10 510(k)s)
• Karl Storz-Endoscopy-America, Inc. (2 510(k)s)
• Karl Leibinger GmbH U. Co. KG (1 510(k)s)
• Karl M. Block Co. (1 510(k)s)
• Karl Storz Endoscopy_America, Inc. (1 510(k)s)
• Karl Storz Endovision, Inc. (1 510(k)s)
• Karl Storz GmbH & Co. (Kst) (1 510(k)s)
• Karl Storz Lithotripsy-America, Inc. (1 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Karl Storz Endoscopy?

FDA lists 35 510(k) clearances under the applicant name “Karl Storz Endoscopy” (first 1995, latest 2005), across 21 product codes in 8 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 Karl Storz Endoscopy?

The median time from FDA receipt to decision across 510(k)s cleared under the name Karl Storz Endoscopy is 81 days.

Which FDA product codes appear under Karl Storz Endoscopy?

The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 6); HRX (Arthroscope, 5); HIH (Hysteroscope (And Accessories), 3).

Next steps

• See all 35 Karl Storz Endoscopy clearances with predicates and recalls
• Run predicate analysis for product code GCJ, Karl Storz Endoscopy'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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