Minerva Surgical, Inc.

Address:4255 Burton Drive,Santa Clara,CA,95054,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar (PGT) (5) Device, Thermal Ablation, Endometrial (MNB) (3) Hysteroscope (And Accessories) (HIH) (2)

Premarket Exempt

No Yes

Clear

Genesys HTA Control Unit - 00850033976014 Catalog Number : M006580010

Device Description : Genesys HTA 115V Control Unit

Device Class : 3

Duns Number: 829616478

Premarket Exempt : No

Product Code : MNB

Prescription Use : Yes

Device Count : 1

Genesys HTA Control Unit - Refurbished - 00850033976021 Catalog Number : M00658001R0

Device Description : Genesys HTA 115V Control Unit (Refurbished)

Device Class : 3

Duns Number: 829616478

Premarket Exempt : No

Product Code : MNB

Prescription Use : Yes

Device Count : 1

Genesys HTA ProCerva - 00850033976038 Catalog Number : M006580210

Device Description : Procedure Set including Procedure Sheath, Cassette, Drainage Bag

Device Class :

Duns Number: 829616478

Premarket Exempt : No

Product Code : MNB

Prescription Use : Yes

Device Count : 1

Symphion Resecting Device - 00850033976076 Catalog Number : FG-0201

Device Description : Symphion Operative Hysteroscopy System Resecting Device for use with Symphion Controller

Device Class : 2

Duns Number: 829616478

Premarket Exempt : No

Product Code : PGT

Prescription Use : Yes

Device Count : 1

Symphion Fluid Management Accessories - 00850033976083 Catalog Number : FG-0202

Device Description : Symphion Operative Hysteroscopy System Fluid Management Accessories for use with Symphion Operative Hysteroscopy System Fluid Management Accessories for use with Symphion Controller

Device Class : 2

Duns Number: 829616478

Premarket Exempt : No

Product Code : PGT

Prescription Use : Yes

Device Count : 1

Symphion Controller - 00850033976090 Catalog Number : FG-0612

Device Description : Symphion Operative Hysteroscopy System Controller with Integrated Fluid Manageme Symphion Operative Hysteroscopy System Controller with Integrated Fluid Management Contents:(1) Symphion Controller(1) Power Cord(1) Footswitch(1) Saline Pole

Device Class : 2

Duns Number: 829616478

Premarket Exempt : No

Product Code : PGT

Prescription Use : Yes

Device Count : 1

Symphion Controller - Refurbished - 00850033976106 Catalog Number : FG-0612-R

Device Description : Symphion Operative Hysteroscopy System Controller with Integrated Fluid Manageme Symphion Operative Hysteroscopy System Controller with Integrated Fluid Management - Refurbished Contents:(1) Symphion Controller(1) Power Cord(1) Footswitch(1) Saline Pole

Device Class : 2

Duns Number: 829616478

Premarket Exempt : No

Product Code : PGT

Prescription Use : Yes

Device Count : 1

Symphion Spare Footswitch - 00850033976113 Catalog Number : FG-0656

Device Description : Symphion Operative Hysteroscopy System Spare Footswitch only for use with Symphi Symphion Operative Hysteroscopy System Spare Footswitch only for use with Symphion Controller

Device Class : 2

Duns Number: 829616478

Premarket Exempt : No

Product Code : PGT

Prescription Use : Yes

Device Count : 1

Symphion 6.3 Hysteroscope - 00850033976120 Catalog Number : FG-0703

Device Description : Symphion Operative Hysteroscopy System 6.3 Hysteroscope for use with Symphion Co Symphion Operative Hysteroscopy System 6.3 Hysteroscope for use with Symphion Controller Contents:(1) Hysteroscope(1) Storz Scope Adapter(1) Wolf Scope Adapter(1) Working Channel Brush(1) Fluid Channel Brush

Device Class : 2

Duns Number: 829616478

Premarket Exempt : No

Product Code : HIH

Prescription Use : Yes

Device Count : 1

Symphion 6.3 Hysteroscope - Refurbished - 00850033976137 Catalog Number : FG-0703-R

Device Description : Symphion Operative Hysteroscopy System 6.3 Hysteroscope for use with Symphion Co Symphion Operative Hysteroscopy System 6.3 Hysteroscope for use with Symphion Controller - RefurbishedContents:(1) Hysteroscope(1) Storz Scope Adapter(1) Wolf Scope Adapter(1) Working Channel Brush(1) Fluid Channel Brush

Device Class : 2

Duns Number: 829616478

Premarket Exempt : No

Product Code : HIH

Prescription Use : Yes

Device Count : 1

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