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Needle, Pneumoperitoneum, Spring Loaded, Reprocessed

Needle, Pneumoperitoneum, Spring Loaded, Reprocessed is a medical device type in the Gastroenterology, Urology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.

Global Registration Data
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Needle, Pneumoperitoneum, Spring Loaded, Reprocessed
Gastroenterology, Urology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

NLX

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Class 2

21 CFR 876.1500

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Gastroenterology, Urology

Device Characteristics

No

No

No

Not Eligible

Definition

The "needle, penum...." is intended to insufflate the peritoneal cavity with gas during endoscopic procedures. This device is indiated for reuse/reprocessing. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).