Gomco Circumcision Clamp
Black Gomco Circumcision Clamp Chrome
2manufacturers in China registered for this device type
16catalogue numbers in this listing
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 | Sontec Instruments, Inc., United States |
|---|---|
| FDA product code | HFX |
| Device type | Clamp, Circumcision |
| Device class | Class 2 |
| Regulation | 21 CFR 884.4530 |
| Establishment | Repacker / relabeller |
| 510(k) | K040052 |
| Record published | 2018-08-22 |
| Record revised | 2018-07-06 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization, Dry Heat Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Lumen/inner diameter 11 to 16 mm; outer diameter 8 to 10 mm |
| Distribution end date | 2018-09-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 540-388B | Outer Diameter 8 mm | In distribution |
| 540-392B | Lumen/Inner Diameter 13 mm | In distribution |
| 540-394 | Lumen/Inner Diameter 14.5 mm | In distribution |
| 540-396 | Lumen/Inner Diameter 16 mm | In distribution |
| 540-392 | Lumen/Inner Diameter 13 mm | In distribution |
| 540-394B | Lumen/Inner Diameter 14.5 mm | In distribution |
| 540-390B | Lumen/Inner Diameter 11 mm | In distribution |
| 540-389 | Outer Diameter 10 mm | Withdrawn |
| 540-392 | Lumen/Inner Diameter 13 mm | Withdrawn |
| 540-388B | Outer Diameter 8 mm | Withdrawn |
| 540-396 | Lumen/Inner Diameter 16 mm | Withdrawn |
| 540-392B | Lumen/Inner Diameter 13 mm | Withdrawn |
| 540-394B | Lumen/Inner Diameter 14.5 mm | Withdrawn |
| 540-396B | Lumen/Inner Diameter 16 mm | Withdrawn |
| 540-394 | Lumen/Inner Diameter 14.5 mm | Withdrawn |
| 540-390B | Lumen/Inner Diameter 11 mm | Withdrawn |
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 | Allied Medical LLC | 9 |
| Circumplast | Emboss Medical Limited | 8 |
| Aesculap | Aesculap AG | 6 |
| Medical Action Industries | Medical Action Industries, Inc. | 4 |
| AccuCirc® | Clinical Innovations, LLC | 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
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.