PINPOINT Endoscopic Fluorescence Imaging System
FDA 510(k) K150956 · Novadaq Technologies, Inc.
510(k) numberK150956
Submission
- Device name
- PINPOINT Endoscopic Fluorescence Imaging System
- Applicant
- Novadaq Technologies, Inc.
Burnaby, CA - Received
- April 9, 2015
- Decision date
- May 23, 2016
- 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
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|---|---|---|
| K162885 | SPY Phi Open Field Handheld Fluorescence Imaging SystemOWN · Traditional | 01/11/2017SE |
| K161792 | PINPOINT Endoscopic Fluorescence Imaging SystemGCJ · Special | 09/20/2016SE |
| K123013 | Endoscopic IntroducerFED · Traditional | 03/22/2013SE |
| K100371 | Spy Intra-Operative Imaging SystemIZI · Traditional | 02/04/2011SE |
| K091515 | Spy Scope Intra-Operative Operating SystemGCJ · Traditional | 07/09/2009SE |
| K081792 | Spy Analysis Toolkit, Model SA9000LLZ · Traditional | 09/17/2008SE |
| K073130 | Spy Fluorescent Imaging SystemIZI · Traditional | 01/10/2008SE |
| K073088 | Spy Fluorescent Imaging SystemIZI · Traditional | 01/10/2008SE |
| K071619 | Spy Fluorescent Imaging SystemIZI · Traditional | 11/09/2007SE |
| K072222 | Spy Fluorescent Imaging SystemIZI · Special | 09/07/2007SE |
Questions and answers
When was PINPOINT Endoscopic Fluorescence Imaging System cleared by the FDA?
PINPOINT Endoscopic Fluorescence Imaging System (K150956) received a 510(k) decision of Substantially Equivalent on May 23, 2016, 410 days after the submission was received.
What is the product code of K150956?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.