Cryoprobe

510(k) K024009

Cryoprobe is a medical device (FDA Class II; FDA product code GEH, Unit, Cryosurgical, Accessories) made by H&O Equipments nv/sa, cleared under FDA 510(k) K024009 on 20 Mar 2003, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K024009↗

FDA record

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK024009	Date20 Mar 2003Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K024009

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K024009
FDA product code: GEH
FDA applicant: H&O Equipments, Nv/Sa

Device class: Class II
Regulation: 21 CFR Part 878.4350
Advisory committee: General, Plastic Surgery
FDA decision: SESE Substantially Equivalent

Devices cleared under K024009

56 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K024009
		UDI-DI	Size and differences
CryoProbe 16g N2O cartridges H & O Equipments SA	S-HO-NOCX-PR-12-S06 / 16g N2O cartridges	B386SHONOCXPR12S061	Prescription: no; Single use: yes	On the market
CryoProbe 23g N2O cartridges H & O Equipments SA	S-HO-NO23-XX-S06-PR / 23g N2O cartridges	B386SHONO23XXS06PR1	Prescription: no; Single use: yes	On the market
CryoProbe 8g N2O cartridges H & O Equipments SA	S-HO-NOCX-12-S24-PR / 8g N2O cartridges	B386SHONOCX12S24PR1	Prescription: no; Single use: yes	On the market
CryoProbe N2O 8g cartridges and filters H & O Equipments SA	S-NOR10 / N2O 8g cartridges and filters	B386SNOR101	Prescription: no; Single use: yes	On the market
CryoProbe\|b special aesthethics H & O Equipments SA	S-HO-CBPLUSPR-02 / CryoProbe\|b special aesthethics	B386SHOCBPLUSPR020	Prescription: no; Single use: no	On the market
CryoProbe\|b Special HPV H & O Equipments SA	S-HO-CBPLUSPR-03 / CryoProbe\|b Special HPV	B386SHOCBPLUSPR030	Prescription: no; Single use: no	On the market
CryoProbe\|m H & O Equipments SA	S-HO-CMPR-XX-902 / CryoProbe\|m	B386SHOCMPRXX9020	Prescription: no; Single use: no	On the market
CryoProbe\|o H & O Equipments SA	S-HO-CXPR-PODO / CryoProbe\|o	B386SHOCXPRPODO0	Prescription: no; Single use: no	On the market
CryoProbe\|x H & O Equipments SA	S-HO-CXPR-XX-801 / CryoProbe\|x	B386SHOCXPRXX8010	Prescription: no; Single use: no	On the market
CryoProbe\|x+ H & O Equipments SA	S-HO-CXPRP-00 / CryoProbe\|x+	B386SHOCXPRP000	Prescription: no; Single use: no	On the market
CryoProbe™ 16g cartridges for CryoProbe H & O Equipments SA	S-HO-NOCX-PRXL-S06 / 16g cartridges for CryoProbe	15407008482302	Prescription: no; Single use: yes	On the market
CryoProbe™ 23g cartridges for CryoProbe H & O Equipments SA	S-HO-NO23-XX-S06-PR / 23g cartridges for CryoProbe	15407008482500	Prescription: no; Single use: yes	On the market
CryoProbe™ 8g cartridges for CryoProbe H & O Equipments SA	S-HO-NOCX-XX-S24-PR / 8g cartridges for CryoProbe	15407008482104	Prescription: no; Single use: yes	On the market
CryoProbe™ CryoProbe B+ H & O Equipments SA	S-HO-CBPLUSPR-05 / CryoProbe B+	B386SHOCBPLUSPR050	Prescription: no; Single use: no	On the market
CryoProbe™ CryoProbe B+ H & O Equipments SA	S-HO-CBPLUSPR-05 / CryoProbe B+	15407008481206	Prescription: no; Single use: no	On the market
CryoProbe™ CryoProbe B+ H & O Equipments SA	S-HO-CBPLUSPR-06 / CryoProbe B+	15407008481213	Prescription: no; Single use: no	On the market
CryoProbe™ CryoProbe M H & O Equipments SA	S-HO-CMPR-XX-902 / CryoProbe M	15407008481008	Prescription: no; Single use: no	On the market
CryoProbe™ CryoProbe O H & O Equipments SA	S-HO-COPR-01 / CryoProbe O	15407008481305	Prescription: no; Single use: no	On the market
CryoProbe™ CryoProbe O+ H & O Equipments SA	S-HO-COPR-02 / CryoProbe O+	15407008481312	Prescription: no; Single use: no	On the market
CryoProbe™ CryoProbe Touch H & O Equipments SA	S-TOUCH-30 / CryoProbe Touch	15407008481404	Prescription: no; Single use: no	On the market
CryoProbe™ CryoProbe X+ H & O Equipments SA	S-HO-CXPRP-01 / CryoProbe X+	15407008481107	Prescription: no; Single use: no	On the market
CryoProbe™ CryoProbe X+ H & O Equipments SA	S-HO-CXPRP-02 / CryoProbe X+	15407008481114	Prescription: no; Single use: no	On the market
CryoProbe™ CryoProbe XP H & O Equipments SA	S-HO-CEPR-00 / CryoProbe XP	15407008481503	Prescription: no; Single use: no	On the market
CryoProbe™ CryoProbe XP H & O Equipments SA	S-HO-CEPR-00 / CryoProbe XP	B386SHOCEPR000	Prescription: no; Single use: no	On the market
CryoProbe™ CryoProbe XP H & O Equipments SA	S-HO-CEPR-01 / CryoProbe XP	15407008481510	Prescription: no; Single use: no	On the market
CryoProbe™ CryoProbe XP+ H & O Equipments SA	S-HO-CEPRPLUS-00 / CryoProbe XP+	15407008481527	Prescription: yes; Single use: no	On the market
CryoProbe™ CryoProbe XPS H & O Equipments SA	S-HO-CESPR-00 / CryoProbe XPS	15407008481602	Prescription: no; Single use: no	On the market
CryoProbe™ CryoProbe \|b White H & O Equipments SA	S-HO-CBPLUSPR-04 / CryoProbe \|b White	B386SHOCBPLUSPR040	Prescription: no; Single use: no	On the market
CryoProbe™ CryoProbe\|o 2018 H & O Equipments SA	S-HO-COPR-01 / CryoProbe\|o 2018	B386SHOCOPR010	Prescription: no; Single use: no	On the market
CryoProbe™ CryoProbe\|x+ 2018 H & O Equipments SA	S-HO-CXPRP-01 / CryoProbe\|x+ 2018	B386SHOCXPRP010	Prescription: no; Single use: no	On the market
CryoProbe™ CryoProbe\|xgyn H & O Equipments SA	S-HO-CXPRP-02 / CryoProbe\|xgyn	B386SHOCXPRP020	Prescription: no; Single use: no	On the market
Freezpen H & O Equipments SA	CL-FP-00 / Freezpen	B386CLFP000	Prescription: no; Single use: no	On the market
Freezpen 8g N2O cartridges for Freezpen H & O Equipments SA	CL-N2O-8G-BOX / 8g N2O cartridges for Freezpen	B386CLN2O8GBOX1	Prescription: no; Single use: yes	On the market
Freezpen® 16g cartridges for Freezpen H & O Equipments SA	CL-N2O-16G-BOX / 16g cartridges for Freezpen	15407008484207	Prescription: no; Single use: yes	On the market
Freezpen® 16g cartridges for Freezpen H & O Equipments SA	CL-N2O-16G-UNBOX / 16g cartridges for Freezpen	B386CLN2O16GUNBOX1	Prescription: no; Single use: yes	On the market
Freezpen® 16g cartridges for Freezpen H & O Equipments SA	CL-N2O-16G-UNBOX / 16g cartridges for Freezpen	15407008484306	Prescription: no; Single use: yes	On the market
Freezpen® 35g cartridges for Freezpen H & O Equipments SA	CL-N2O-35G-UBOX / 35g cartridges for Freezpen	15407008484504	Prescription: no; Single use: yes	On the market
Freezpen® 8g cartridges for Freezpen H & O Equipments SA	CL-N2O-8G-BOX / 8g cartridges for Freezpen	15407008484009	Prescription: no; Single use: yes	On the market
Freezpen® 8g cartridges for Freezpen H & O Equipments SA	CL-N2O-8G-UNBOX / 8g cartridges for Freezpen	15407008484108	Prescription: no; Single use: yes	On the market
Freezpen® 8g cartridges for Freezpen H & O Equipments SA	CL-N2O-8G-UNBOX / 8g cartridges for Freezpen	B386CLN2O8GUNBOX1	Prescription: no; Single use: yes	On the market
Freezpen® Freezpen 16G H & O Equipments SA	CL-FP-16 / Freezpen 16G	B386CLFP160	Prescription: no; Single use: no	On the market
Freezpen® Freezpen 16g H & O Equipments SA	CL-FPU-18 / Freezpen 16g	15407008483309	Prescription: no; Single use: no	On the market
Freezpen® Freezpen 35G H & O Equipments SA	CL-FPU-35 / Freezpen 35G	15407008483507	Prescription: no; Single use: no	On the market
Freezpen® Freezpen 35g H & O Equipments SA	CL-FPU-36 / Freezpen 35g	15407008483514	Prescription: yes; Single use: no	On the market
Freezpen® Freezpen 8G H & O Equipments SA	CL-FP-01 / Freezpen 8G	B386CLFP010	Prescription: no; Single use: no	On the market
Freezpen® Freezpen 8g H & O Equipments SA	CL-FPU-02 / Freezpen 8g	15407008483101	Prescription: no; Single use: no	On the market
Freezpen® Freezpen 8G H & O Equipments SA	CL-FPU-02 / Freezpen 8G	B386CLFPU020	Prescription: no; Single use: no	On the market
Freezpen® Freezpen 8g H & O Equipments SA	CL-FPU-03 / Freezpen 8g	15407008483118	Prescription: no; Single use: no	On the market
FrostAway™ FrostAway Pen H & O Equipments SA	FROSTAWAYPEN / FrostAway Pen	15407008487000	Prescription: yes; Single use: no	On the market
FrostAway™ FrostAway Pen cartridges H & O Equipments SA	FROSTAWAYPEN-CA / FrostAway Pen cartridges	15407008487017	Prescription: yes; Single use: yes	On the market

Similar devices

Other devices filed under FDA product code GEH (Unit, Cryosurgical, Accessories).

Other devices from H&O Equipments nv/sa

Freezpen 16g

Class IIa
Freezpen 35g

Class IIa
CryoPen X+

Class IIa
CryoPen O+

Class IIa

See all devices from H&O Equipments nv/sa →

Regulatory status

Coverage

Specification

Related clearances

Cited by

Devices cleared under K024009

Similar devices

Other devices from H&O Equipments nv/sa

Freezpen 16g

Freezpen 35g

CryoPen X+

CryoPen O+