AccuCirc®
AccuCirc® Circumcision Device
2manufacturers in China registered for this device type
4catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (1), Anhui (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Wuhu Snnda Medical Treatment Appliance Technology Co., Ltd. | Wuhu | Anhui | Manufacturer | 1 |
Record
| Listed by | Clinical Innovations, LLC, United States |
|---|---|
| FDA product code | HFX |
| Device type | Clamp, Circumcision |
| Device class | Class 2 |
| Regulation | 21 CFR 884.4530 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K061539 |
| Record published | 2016-09-01 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 4, pack of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CIRC-1150 | In distribution | |
| CIRC-1300 | In distribution | |
| CIRC-1350 | In distribution | |
| CIRC-1100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ShangRing | Wuhu Snnda Medical Treatment Appliance Technology Co., Ltd. | 24 |
| Centurion | Centurion Medical Products Corporation | 18 |
| Devon | Cardinal Health | 17 |
| Gomco Circumcision Clamp | Sontec Instruments, Inc. | 16 |
| Gomco | Allied Medical LLC | 9 |
| Circumplast | Emboss Medical Limited | 8 |
| Aesculap | Aesculap AG | 6 |
| Medical Action Industries | Medical Action Industries, Inc. | 4 |
| Gomco Type Circumcision Clamp | Fine Surgical Instruments Inc. | 4 |
| Medline | Medline Industries, Inc. | 3 |
| Mogen Circumcision Clamp | Sontec Instruments, Inc. | 2 |
| Gomco Circumcision Clamp Chrome | Sontec Instruments, Inc. | 2 |
Showing 12 of 21. All products under Clamp, Circumcision
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K061539 | 2007-09-20 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.