PINPOINT Endoscopic Fluorescence Imaging System
FDA 510(k) K182606 · Novadaq Technologies Ulc. (Now A Part of Stryker)
510(k) numberK182606
Submission
- Device name
- PINPOINT Endoscopic Fluorescence Imaging System
- Applicant
- Novadaq Technologies Ulc. (Now A Part of Stryker)
Burnaby, CA - Received
- September 21, 2018
- Decision date
- November 21, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GCJ – Laparoscope, General & Plastic Surgery
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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More from TroCare, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K202244 | SPY-PHI System with SPY-PHI Fluorescence Assessment SoftwareOWN · Traditional | 11/05/2020SE |
| K200737 | SPY Portable Handheld Imaging (SPY-PHI) SystemOWN · Traditional | 05/21/2020SE |
| K192174 | SPY Portable Handheld Imaging (SPY-PHI) SystemOWN · Traditional | 11/15/2019SE |
| K190729 | SPY Portable Handheld Imaging (SPY-PHI) SystemOWN · Special | 04/19/2019SESD |
| K182907 | SPY Elite Intraoperative Perfusion Assessment SystemIZI · Traditional | 01/23/2019SE |
Questions and answers
When was PINPOINT Endoscopic Fluorescence Imaging System cleared by the FDA?
PINPOINT Endoscopic Fluorescence Imaging System (K182606) received a 510(k) decision of Substantially Equivalent on November 21, 2018, 61 days after the submission was received.
What is the product code of K182606?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.