Frigitronics
Leebron Anorectal Probe. Tip Dimension: 9.5mm diameter x 30.5mm long. Flat surface: 5mm x 25mm.
3manufacturers in China registered for this device type
42catalogue numbers in this listing
16recalls on this code
Who Else Makes It
Concentrated in Guangdong (1), Beijing (1), Tianjin (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Kesite Digital Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 4 |
| Hygea Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
| Medinux (Tianjin) Technologies Co., Ltd. | Tianjin | Tianjin | Manufacturer | 1 |
Record
| Listed by | Coopersurgical, Inc., United States |
|---|---|
| FDA product code | GEH |
| Device type | Unit, Cryosurgical, Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4350 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K840536 |
| Record published | 2016-08-02 |
| Record revised | 2024-02-28 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
| Sizes | Outer diameter 2 to 25 mm; length 4 to 20 mm; length 1 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 693 | In distribution | |
| 2447 | Length 4 mm | In distribution |
| 2400 | In distribution | |
| 2458 | In distribution | |
| 664 | Length 9 mm | In distribution |
| 697 | Length 20 mm | In distribution |
| 5900-1A | In distribution | |
| 2402 | In distribution | |
| 2445 | Length 17 mm | In distribution |
| 684 | Length 4 mm | In distribution |
| 5215 | In distribution | |
| 5213 | In distribution | |
| 683I | In distribution | |
| 2440 | Outer Diameter 6 mm | In distribution |
| 5212 | In distribution | |
| 5235 | In distribution | |
| 5227 | In distribution | |
| 2442 | Length 9 mm | In distribution |
| 2401 | In distribution | |
| 5232 | In distribution | |
| 5234 | In distribution | |
| 2463 | In distribution | |
| 689 | Length 4 mm | In distribution |
| 665 | Length 10 mm | In distribution |
| 2446 | Length 4 mm | In distribution |
| 2457 | In distribution | |
| 5228 | In distribution | |
| 663 | Length 15 mm | In distribution |
| 5237 | In distribution | |
| 698 | Length 20 mm | In distribution |
| 2443 | Length 8 mm | In distribution |
| 5214 | In distribution | |
| 667 | Length 8 mm | In distribution |
| 673 | Length 17 mm | In distribution |
| 683 | In distribution | |
| 2444 | Length 15 mm | In distribution |
| 2441 | Length 4.5 mm | In distribution |
| 688 | Length 20 mm | In distribution |
| 5238 | In distribution | |
| 2461 | In distribution | |
| 2449 | Length 1 cm | In distribution |
| 666 | Length 4.5 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CryoProbe™ | H&O Equipments, Nv/Sa | 35 |
| Wallach | Coopersurgical, Inc. | 32 |
| Premier | Premier Dental Products Co. | 30 |
| Hygea | Hygea Medical Technology Co., Ltd. | 26 |
| truFreeze | CSA Medical | 20 |
| Freezpen® | H&O Equipments, Nv/Sa | 19 |
| Leisegang Cryotip for LM-900 | Coopersurgical, Inc. | 15 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 13 |
| cryoICE Cryoablation System | Atricure, Inc. | 13 |
| CryoThin | Medinux (Tianjin) Technologies Co., Ltd. | 12 |
| Erbe | Erbe Elektromedizin GmbH | 12 |
| CVS Health | Woonsocket Prescription Center, Incorporated | 10 |
Showing 12 of 334. All products under Unit, Cryosurgical, Accessories
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2015-03-09 | Class II | Under Investigation by firm | Internal gas line may malfunction causing the line to burst under pressure. | 255 units | 2016-02-01 |
| 2009-09-29 | Not classified | Device Design | CO2 Cryosystem thermal load may exceed the exhaust gas phase, resulting in ice formation in the exhaust valve. Should this occur, the Cryo tip may cool at a less than optimal rate, resulting in ice formation in the exhaust valve. | 2012-04-17 | |
| 2009-09-29 | Not classified | Device Design | CO2 Cryosystem thermal load may exceed the exhaust gas phase, resulting in ice formation in the exhaust valve. Should this occur, the Cryo tip may cool at a less than optimal rate, resulting in ice formation in the exhaust valve. | 2012-04-17 | |
| 2009-09-29 | Not classified | Device Design | CO2 Cryosystem thermal load may exceed the exhaust gas phase, resulting in ice formation in the exhaust valve. Should this occur, the Cryo tip may cool at a less than optimal rate, resulting in ice formation in the exhaust valve. | 3,044 units | 2012-04-17 |
| 2009-09-29 | Not classified | Device Design | CO2 Cryosystem thermal load may exceed the exhaust gas phase, resulting in ice formation in the exhaust valve. Should this occur, the Cryo tip may cool at a less than optimal rate, resulting in ice formation in the exhaust valve. | 2012-04-17 | |
| 2009-09-29 | Not classified | Device Design | CO2 Cryosystem thermal load may exceed the exhaust gas phase, resulting in ice formation in the exhaust valve. Should this occur, the Cryo tip may cool at a less than optimal rate, resulting in ice formation in the exhaust valve. | 2012-04-17 | |
| 2009-09-29 | Not classified | Device Design | CO2 Cryosystem thermal load may exceed the exhaust gas phase, resulting in ice formation in the exhaust valve. Should this occur, the Cryo tip may cool at a less than optimal rate, resulting in ice formation in the exhaust valve. | 2012-04-17 | |
| 2009-09-29 | Not classified | Device Design | CO2 Cryosystem thermal load may exceed the exhaust gas phase, resulting in ice formation in the exhaust valve. Should this occur, the Cryo tip may cool at a less than optimal rate, resulting in ice formation in the exhaust valve. | 2012-04-17 | |
| 2009-09-29 | Not classified | Device Design | CO2 Cryosystem thermal load may exceed the exhaust gas phase, resulting in ice formation in the exhaust valve. Should this occur, the Cryo tip may cool at a less than optimal rate, resulting in ice formation in the exhaust valve. | 2012-04-17 | |
| 2009-09-29 | Not classified | Device Design | CO2 Cryosystem thermal load may exceed the exhaust gas phase, resulting in ice formation in the exhaust valve. Should this occur, the Cryo tip may cool at a less than optimal rate, resulting in ice formation in the exhaust valve. | 2012-04-17 | |
| 2009-09-29 | Not classified | Device Design | CO2 Cryosystem thermal load may exceed the exhaust gas phase, resulting in ice formation in the exhaust valve. Should this occur, the Cryo tip may cool at a less than optimal rate, resulting in ice formation in the exhaust valve. | 2012-04-17 | |
| 2009-09-29 | Not classified | Device Design | CO2 Cryosystem thermal load may exceed the exhaust gas phase, resulting in ice formation in the exhaust valve. Should this occur, the Cryo tip may cool at a less than optimal rate, resulting in ice formation in the exhaust valve. | 2012-04-17 | |
| 2009-09-29 | Not classified | Device Design | CO2 Cryosystem thermal load may exceed the exhaust gas phase, resulting in ice formation in the exhaust valve. Should this occur, the Cryo tip may cool at a less than optimal rate, resulting in ice formation in the exhaust valve. | 2012-04-17 | |
| 2009-09-29 | Not classified | Device Design | CO2 Cryosystem thermal load may exceed the exhaust gas phase, resulting in ice formation in the exhaust valve. Should this occur, the Cryo tip may cool at a less than optimal rate, resulting in ice formation in the exhaust valve. | 2012-04-17 | |
| 2007-06-06 | Not classified | Device Design | The tip may separate from the probe. | 315 units | 2015-07-15 |
| 2007-06-06 | Not classified | Device Design | The tip may separate from the probe. | 14 units | 2015-07-15 |
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.