Cabot Medical Corp.: FDA filings under this applicant name
FDA lists 38 510(k) clearances under the applicant name “Cabot Medical Corp.” (first 1983, latest 1996), across 21 product codes in 6 review panels. Median 510(k) review time under this name: 97 days. 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
| 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 7 | 7 |
| HET | Laparoscope, Gynecologic (And Accessories) | 3 | 3 |
| HIG | Insufflator, Hysteroscopic | 3 | 3 |
| HRX | Arthroscope | 3 | 3 |
| GEX | Powered Laser Surgical Instrument | 2 | 2 |
| HGI | Electrocautery, Gynecologic (And Accessories) | 2 | 2 |
| HIF | Insufflator, Laparoscopic | 2 | 2 |
| HIH | Hysteroscope (And Accessories) | 2 | 2 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 2 | 2 |
| DWJ | System, Thermal Regulating | 1 | 1 |
Plus 11 more product codes.
Review panels
- Obstetrics and Gynecology (17)
- General and Plastic Surgery (9)
- Gastroenterology and Urology (6)
- Orthopedic (4)
- Cardiovascular (1)
- General Hospital (1)
Most recent Cabot Medical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K960148 | CIRCON-SURGITEK CLASSIC DOUBLE PIGTAIL URETERAL STENT | FAD | 1996-03-25 | 74 |
| K946109 | CABOT MEDICAL REUSABLE BIPOLAR CUTTING FORCEPS | KNS | 1995-11-21 | 342 |
| K951972 | CABOT MEDICAL ULTRA FLOW CYSTOURETHROSCOPE SYSTEM WITH OPERATING & DIAGNOSTIC SHEATHS | FBO | 1995-07-21 | 85 |
| K951714 | CABOT MEDICAL-SURGITEK ULTRAGOLD PLUS SIDE-FIRING UROLOGIC LASER FIBER | GEX | 1995-07-11 | 88 |
| K941743 | CABOT MEDICAL NIAGARA FLUID MANAGEMENT PUMP | HIG | 1995-04-19 | 377 |
| K934115 | 3000 ELECTRONIC INSUFFLATOR MODIFICATION | HIF | 1995-03-15 | 568 |
| K932293 | CABOT MEDICAL BIPOLAR CUTTING FORCEPS | KNS | 1994-07-27 | 442 |
| K930954 | THE CABOT MEDICAL INSUL-SHETH VAGINAL SPECULUM COV | HIB | 1994-06-30 | 492 |
| K932626 | CABOT MEDICAL SURGIFLEX(R) SUCTION-IRRIGATION PROB | GCJ | 1994-06-08 | 372 |
| K935786 | CORSON AND NEZHAT SUCTION/IRRIGATION PROBES | GCJ | 1994-05-19 | 164 |
28 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Cabot Medical Corp..
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.
- Cabot Safety Corp. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cabot Medical Corp.?
FDA lists 38 510(k) clearances under the applicant name “Cabot Medical Corp.” (first 1983, latest 1996), across 21 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 Cabot Medical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cabot Medical Corp. is 97 days.
Which FDA product codes appear under Cabot Medical Corp.?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 7); HET (Laparoscope, Gynecologic (And Accessories), 3); HIG (Insufflator, Hysteroscopic, 3).
Next steps
- See all 38 Cabot Medical Corp. clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Cabot Medical Corp.'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.