pinnaclemedtech.comNuvis Battery Arthroscope
Integrated Endoscopy, Inc.
INTEGRATED ENDOSCOPY, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3011401113 | 3011401113 | INTEGRATED ENDOSCOPY, INC. | 1 | N | 2026-01-01 | 16 Technology Drive, Suite 165 Irvine CA US 92618 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 08538160080010 | Nuvis - The NuVis™ Arthroscope is a non-deflectable rigid endoscopic optical instrument designed for illumination and visualization of internal anatomy of a patient within the knee, shoulder, hip, wrist, temporal mandibular joint, ankle, elbow, and feet joints. Integrated Endoscopy’s NuVis Arthroscope has a 140mm working length, an outside diameter of 4mm, a field of view of 105°, and a direction of view of 30°. The Arthroscope is designed to be used with a cannula compatible with a 4mm x 30° arthroscope with a working length of 140mm. The Arthroscope is supplied sterile and is for single-use only. It is not intended to be re-used or re-sterilized. | 17149552400 | tom@pinnaclemedtech.com |
| 08538160080027 | Nuvis - The NuVis™ Arthroscope is a non-deflectable rigid endoscopic optical instrument designed for illumination and visualization of internal anatomy of a patient within the knee, shoulder, hip, wrist, temporal mandibular joint, ankle, elbow, and feet joints. Integrated Endoscopy’s NuVis Arthroscope has a 140mm working length, an outside diameter of 4mm, a field of view of 105°, and a direction of view of 30°. The Arthroscope is designed to be used with a cannula compatible with a 4mm x 30° arthroscope with a working length of 140mm. The Arthroscope is supplied sterile and is for single-use only. It is not intended to be re-used or re-sterilized. | 17149552400 | tom@pinnaclemedtech.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 179331 | 1533291795 | K242606 | Nuvis® Wireless HD Camera System (Nuvis-2K) | GCJ | 2025-11-20 |
| 179331 | 1451492036 | K191594 | Nuvis Battery Arthroscope | HRX | 2019-07-11 |
| 179331 | 1867699271 | K140903 | NUVIS ARTHROSCOPE | HRX | 2014-07-17 |
| 179331 | 1681568334 |
Product Codes Associated With Registrations#
PMN#
NUVIS ARTHROSCOPE
INTEGRATED ENDOSCOPY, INC.
GUDID#
Nuvis - The NuVis™ Arthroscope is a non-deflectable rigid endoscopic optical instrument designed for illumination and visualization of internal anatomy of a patient within the knee, shoulder, hip, wrist, temporal mandibular joint, ankle, elbow, and feet joints. Integrated Endoscopy’s NuVis Arthroscope has a 140mm working length, an outside diameter of 4mm, a field of view of 105°, and a direction of view of 30°. The Arthroscope is designed to be used with a cannula compatible with a 4mm x 30° arthroscope with a working length of 140mm. The Arthroscope is supplied sterile and is for single-use only. It is not intended to be re-used or re-sterilized.
2018-02-08
Nuvis - The Nuvis® Arthroscope is a non-deflectable rigid endoscopic optical instrument designed for illumination and visualization of internal anatomy of a patient within the knee, shoulder, hip, wrist, temporal mandibular joint, ankle, elbow, and feet joints. Integrated Endoscopy’s Nuvis Arthroscope has a 142mm working length, an outside diameter of 4mm, a field of view of 105°, and a direction of view of 30°. The Arthroscope is designed to be used with a cannula compatible with a 4mm x 30° arthroscope with a working length of 142mm. The Arthroscope is supplied sterile and is for single-use only. It is not intended to be re-used or re-sterilized.
2020-03-30
Nuvis - The Nuvis® Arthroscope is a non-deflectable rigid endoscopic optical instrument designed for illumination and visualization of internal anatomy of a patient within the knee, shoulder, hip, wrist, temporal mandibular joint, ankle, elbow, and feet joints. Integrated Endoscopy’s NuVis Arthroscope has a 142mm working length, an outside diameter of 4mm, a field of view of 105°, and a direction of view of 30°. The Arthroscope is designed to be used with a cannula compatible with a 4mm x 30° arthroscope with a working length of 142mm. The Arthroscope is supplied sterile and is for single-use only. It is not intended to be re-used or re-sterilized. This is the 10-pack configuration.
2020-03-30
Nuvis - The cannula is a stainless-steel tube with no taper at the end, through which the Nuvis® arthroscope can be inserted into the body during arthroscopic surgery. It must be rigid and strong enough to protect the arthroscope from bending, breaking, chipping and any other potential damage that could befall the arthroscope during normal use. It will be able to accommodate the 4mm diameter of the arthroscope, while still leaving enough room for fluid movement. It must be an adequate length to protect the tip, but not long enough to block its image. This cannula version is named as dual rotating stopcock. This dual stopcock version is leak proof when used with an arthroscope, obturator, or trocar. The cannula locking mechanism is modeled after the Stryker SpeedLock™, so as to keep it similar to what the customer is used to. The cannula will be sold as a reusable non-sterile device and distributed independently. Each instrument is cleaned then sterilized by steam autoclave per customer policy and procedure.
2020-03-30
Nuvis - The cannula is a stainless-steel tube with no taper at the end, through which the Nuvis® arthroscope can be inserted into the body during arthroscopic surgery. It must be rigid and strong enough to protect the arthroscope from bending, breaking, chipping and any other potential damage that could befall the arthroscope during normal use. It will be able to accommodate the 4mm diameter of the arthroscope, while still leaving enough room for fluid movement. It must be an adequate length to protect the tip, but not long enough to block its image. This cannula version is named as single rotating stopcock. This single stopcock version is leak proof when used with an arthroscope, obturator, or trocar. The cannula locking mechanism is modeled after the Stryker SpeedLock™, so as to keep it similar to what the customer is used to. The cannula will be sold as a reusable non-sterile device and distributed independently. Each instrument is cleaned then sterilized by steam autoclave per customer policy and procedure.
2020-03-30
Nuvis - The obturator is a solid stainless steel needle used with cannula to close or block up the cannula opening. The obturator will be sold as a reusable non-sterile device and distributed independently. Each instrument is cleaned then sterilized by steam autoclave per customer policy and procedure.
2020-03-30
Nuvis - The trocar is a solid stainless needle used with cannula to close or block up the cannula opening. The trocar is identical to the obturator except the distal end is sharp whose purpose is to be able to cut into muscle/tendon. The trocar will be sold as a reusable non-sterile device and distributed independently. Each instrument is cleaned then sterilized by steam autoclave per customer policy and procedure.
2020-03-30
Nuvis - The NuVis™ Arthroscope is a non-deflectable rigid endoscopic optical instrument designed for illumination and visualization of internal anatomy of a patient within the knee, shoulder, hip, wrist, temporal mandibular joint, ankle, elbow, and feet joints. Integrated Endoscopy’s NuVis Arthroscope has a 140mm working length, an outside diameter of 4mm, a field of view of 105°, and a direction of view of 30°. The Arthroscope is designed to be used with a cannula compatible with a 4mm x 30° arthroscope with a working length of 140mm. The Arthroscope is supplied sterile and is for single-use only. It is not intended to be re-used or re-sterilized.
2018-02-08