United States Endoscopy Group, Inc.: FDA filings under this applicant name

FDA lists 94 510(k) clearances under the applicant name “United States Endoscopy Group, Inc.” (first 1991, latest 2020), across 35 product codes in 6 review panels. Median 510(k) review time under this name: 87 days. Since 2017 the median was 36 days, against 117 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.

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

510(k) clearances per year

Review time against the same product codes

Since 2017, 510(k)s cleared under the name United States Endoscopy Group, Inc. took a median 36 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 117 days.

Top product codes

Plus 25 more product codes.

Review panels

• Gastroenterology and Urology (69)
• General and Plastic Surgery (17)
• Cardiovascular (2)
• General Hospital (2)
• Neurology (2)
• Obstetrics and Gynecology (2)

Most recent United States Endoscopy Group, Inc. 510(k) clearances

84 earlier clearances. See the full list in Caduvo.

Recalls

openFDA lists no recalls under a recalling firm named United States Endoscopy Group, Inc..

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.

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.

• United States Surgical, A Division of Tyco Healthc (218 510(k)s)
• United Orthopedic Corporation (61 510(k)s)
• United Biotech, Inc. (22 510(k)s)
• United Consortium (15 510(k)s)
• United Diagnostics, Inc. (12 510(k)s)
• United Medical Industries Co. , Ltd. (10 510(k)s)
• United Surgical Corp. (7 510(k)s)
• United Pacific Co., Ltd. (6 510(k)s)
• United Dental Mfg., Inc. (5 510(k)s)
• United Medical Systems, Inc. (5 510(k)s)
• United Sonics, Inc. (5 510(k)s)
• United Medical (4 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under United States Endoscopy Group, Inc.?

FDA lists 94 510(k) clearances under the applicant name “United States Endoscopy Group, Inc.” (first 1991, latest 2020), across 35 product codes in 6 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 United States Endoscopy Group, Inc.?

The median time from FDA receipt to decision across 510(k)s cleared under the name United States Endoscopy Group, Inc. is 87 days. Since 2017: 36 days, versus 117 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under United States Endoscopy Group, Inc.?

The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 11); FDI (Snare, Flexible, 10); FEQ (Pump, Air, Non-Manual, For Endoscope, 6).

Next steps

• See all 94 United States Endoscopy Group, Inc. clearances with predicates and recalls
• Run predicate analysis for product code GCJ, United States Endoscopy Group, Inc.'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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