FDA Registration
Active
🇺🇸 United States
ATC TECHNOLOGIES INC.
Reg #: 1225798
·
FEI: 3001595430
·
Expires 2026
Products
13
Proprietary Names
3
Establishment Types
2
Classifications
13
Registration Details
- Registration Name
- ATC TECHNOLOGIES INC.
- Registration Number
- 1225798
- FEI Number
- 3001595430
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 30-B Upton Drive
- City
- Wilmington
- State
- MA
- ZIP
- 01887
- Country
- US
Regulatory Submissions
- 510(k) Number
- K983623
Owner / Operator
- Firm Name
- ATC Technologiess Inc.
- Operator Number
- 10027340
- Address
- 30-B Upton Drive
- City
- Wilmington
- State
- MA
- Postal Code
- 01887
- Country
- US
- Correspondent
- Paul C Kierce
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Insufflator, Laparoscopic | HIF | Class 2 | Obstetrics/Gynecology | No | 2025-12-19 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2008-10-27 |
| Fastener, Fixation, Biodegradable, Soft Tissue | MAI | Class 2 | Orthopedic | No | 2022-12-14 |
| Lens, Contact, Polymethylmethacrylate, Diagnostic | HJK | Class 2 | Ophthalmic | No | 2015-03-18 |
| Prism, Gonioscopic | HKS | Class 1 | Ophthalmic | No | 2014-11-20 |
| Lens, Condensing, Diagnostic | HJL | Class 1 | Ophthalmic | No | 2014-11-20 |
| Catheter, Nephrostomy | LJE | Class U | Unknown | No | 2019-12-23 |
| Hysteroscope (And Accessories) | HIH | Class 2 | Obstetrics/Gynecology | No | 2020-12-30 |
| Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | KNF | Class 2 | Obstetrics/Gynecology | No | 2013-12-27 |
| Topical Approximation System | MZR | Class 1 | General Hospital | No | 2020-12-31 |
| Tonometer, Manual | HKY | Class 2 | Ophthalmic | No | 2015-12-29 |
| Device, Biopsy, Endomyocardial | DWZ | Class 2 | Cardiovascular | No | 2008-10-27 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2008-10-27 |
Proprietary Names
Modulap
Moduloop
Sparrowhawk
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device