Identity
- Trade Name
- Anovo Vaginal Access Kit FDA UDI
- Generic Name
- Laparoscopic surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- The Anovo Surgical System is a robotic-assisted device intended for use by laparoscopic trained physicians for endoscopic manipulation of tissue, using graspers and electrosurgery devices during single-site laparoscopic gynecologic procedures such as benign hysterectomy and salpingo-oophorectomy through a transvaginal access point. The system composed of Anovo Surgeon Console, two sterile instruments (Anovo Instrument ARMS), bed-mounted Robotic Control Unit (RCU) and Anovo System Accessories (Unit cables, Sterile Drapes, Robotic Control Unit Support System (RCUSS) and Vaginal Access Kit). The Vaginal Access Kit contains several accessories which facilitate insertion of the Anovo Instrument ARMS transvaginally. The kit contains: Cannula Connector (UDI # 07290018151174) Cannula (Short - UDI # 07290018151211 and long - UDI # 07290018151242) Cannula Obturator Needle (UDI # 07290018151167) ARMS Entry Guide (UDI # 07290018151235) Blunt Cannula Obturator (UDI # 07290018151198) Mini Introducer (UDI # 07290018151181) Vaginal Access Fixator (UDI # 07290018151204, includes attached Guiding Rail) Cannula Seal Extraction Tool (UDI # 07290018151228) and seals (Cannula Seal and ARMS Entry Guide Seal) The cannula and the ARMS Entry Guide sealed with a disposable seals (gaskets) when inserted into the Applied Medical GelPoint Mini Access Platform. FDA UDI
- Model / Reference
- - FDA UDI
- Description
- The Anovo Surgical System is a robotic-assisted device intended for use by laparoscopic trained physicians for endoscopic manipulation of tissue, using graspers and electrosurgery devices during single-site laparoscopic gynecologic procedures such as benign hysterectomy and salpingo-oophorectomy through a transvaginal access point. The system composed of Anovo Surgeon Console, two sterile instruments (Anovo Instrument ARMS), bed-mounted Robotic Control Unit (RCU) and Anovo System Accessories (Unit cables, Sterile Drapes, Robotic Control Unit Support System (RCUSS) and Vaginal Access Kit). The Vaginal Access Kit contains several accessories which facilitate insertion of the Anovo Instrument ARMS transvaginally. The kit contains: Cannula Connector (UDI # 07290018151174) Cannula (Short - UDI # 07290018151211 and long - UDI # 07290018151242) Cannula Obturator Needle (UDI # 07290018151167) ARMS Entry Guide (UDI # 07290018151235) Blunt Cannula Obturator (UDI # 07290018151198) Mini Introducer (UDI # 07290018151181) Vaginal Access Fixator (UDI # 07290018151204, includes attached Guiding Rail) Cannula Seal Extraction Tool (UDI # 07290018151228) and seals (Cannula Seal and ARMS Entry Guide Seal) The cannula and the ARMS Entry Guide sealed with a disposable seals (gaskets) when inserted into the Applied Medical GelPoint Mini Access Platform. FDA UDI
Identifiers
- Catalog Number
- FP-04-0003 FDA UDI
- Primary DI / UDI-DI
- 27290018151154 FDA UDI
- FDA Product Code
- QNM FDA UDI
- GMDN Term
- Laparoscopic surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4961 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Laparoscopic surgical procedure kit, non-medicated, reusable
Anovo Vaginal Access Kit by Momentis Surgical Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Momentis Surgical Ltd
Sources (1)
- FDA UDI 32dd9514-1306-4b6d-ae57-33b6dccf0e17 36 fields · synced Jun 1, 2026