Medical Device Manufacturer · US , Sioux Falls , SD

Grumpy Innovation, Inc. - FDA 510(k) Cleared Devices

1 submissions · 1 cleared · Since 2025
1
Total
1
Cleared
0
Denied

Grumpy Innovation, Inc. develops advanced wireless endoscopy systems for diagnostic imaging. The company is based in Sioux Falls, US, and specializes in innovative medical device technology that eliminates traditional cable constraints.

The company has received 1 FDA 510(k) clearance from 1 total submission. Grumpy Innovation focuses exclusively on Ear, Nose, Throat devices, with its flagship product cleared in 2025. The company remains active, demonstrating ongoing commitment to regulatory compliance and innovation in diagnostic endoscopy.

The PORTARE Wireless HD Nasopharyngoscope represents the company's core offering-a portable, battery-powered diagnostic system designed for nasopharyngoscopy procedures. The device delivers 1080p imaging with minimal-latency transmission and extended battery life for clinical flexibility.

For detailed information on cleared devices, product codes, and clearance dates, consult the FDA 510(k) database or contact the company directly.

FDA 510(k) Regulatory Record - Grumpy Innovation, Inc.
1 devices
1-1 of 1
Filters
All1 Ear, Nose, Throat 1