Circon Acmi: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Circon Acmi” (first 1988, latest 2002), across 7 product codes in 4 review panels. Median 510(k) review time under this name: 92 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 Olympus, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 4 | 4 |
| CCW | Laryngoscope, Rigid | 1 | 1 |
| FFK | Lithotriptor, Electro-Hydraulic | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| HIF | Insufflator, Laparoscopic | 1 | 1 |
| HIG | Insufflator, Hysteroscopic | 1 | 1 |
| ODC | Endoscope Channel Accessory | 1 | 1 |
Review panels
- Gastroenterology and Urology (6)
- Obstetrics and Gynecology (2)
- Anesthesiology (1)
- General and Plastic Surgery (1)
Most recent Circon Acmi 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K013165 | USA SERIES LAPAROSCOPES | GCJ | 2002-01-18 | 119 |
| K980492 | AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F) | FFK | 1998-11-17 | 281 |
| K905706 | GYN-1500 HYSTEROSCOPIC INUFFLATOR | HIG | 1991-02-28 | 66 |
| K905705 | LAP 3501 HIGH FLOW INSUFFLATOR | HIF | 1991-02-28 | 66 |
| K884097 | MORRIS ANTI-SPLATTER DEVICE FOR ENDOSCOPES | ODC | 1989-04-17 | 201 |
| K884025 | CIRCON ACMI BICAP II THERAPEUTIC SYSTEM BC-200 | KNS | 1989-03-03 | 162 |
| K884254 | CIRCON ACMI BICAP III THERAPEUTIC SYSTEM | KNS | 1989-01-11 | 92 |
| K884252 | CIRCON ACMI BICAP HEMORRHOID SYSTEM BH-10 & BHP-20 | KNS | 1989-01-10 | 91 |
| K884306 | BICAP ABLATING FORCEPS BAF-7 | KNS | 1989-01-05 | 84 |
| K883819 | BULLARD INTUBATING LARYNGOSCOPE LAR-A & LAR-P | CCW | 1988-10-17 | 39 |
Recalls
openFDA lists no recalls under a recalling firm named Circon Acmi.
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.
- Circon Video (14 510(k)s)
- Circon Corp. (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Circon Acmi?
FDA lists 10 510(k) clearances under the applicant name “Circon Acmi” (first 1988, latest 2002), across 7 product codes in 4 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 Circon Acmi?
The median time from FDA receipt to decision across 510(k)s cleared under the name Circon Acmi is 92 days.
Which FDA product codes appear under Circon Acmi?
The most frequent FDA product codes under this applicant name are KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories), 4); CCW (Laryngoscope, Rigid, 1); FFK (Lithotriptor, Electro-Hydraulic, 1).
Next steps
- See all 10 Circon Acmi clearances with predicates and recalls
- Run predicate analysis for product code KNS, Circon Acmi'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.