Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Peralta Stone Removal Catheter

K-Number: K190492 · 2019-07-18

ApplicantCalcula Technologies, Inc.
Decision Date2019-07-18
Product CodeFFL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Peralta Stone Removal Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Calcula Technologies, Inc.. It received FDA 510(k) clearance on 2019-07-18 under 510(k) number K190492. The device is classified under product code FFL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Peralta Stone Removal Catheter?

Peralta Stone Removal Catheter is a medical device that received FDA 510(k) clearance on 2019-07-18. The listed applicant is Calcula Technologies, Inc.. The 510(k) number is K190492.

When did Peralta Stone Removal Catheter receive FDA 510(k) clearance?

Peralta Stone Removal Catheter received FDA 510(k) clearance on 2019-07-18, under 510(k) number K190492.

Who is the listed applicant for Peralta Stone Removal Catheter?

The FDA 510(k) record lists Calcula Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Peralta Stone Removal Catheter?

The FDA product code for Peralta Stone Removal Catheter is FFL.

Related Devices (Code: FFL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K172299Accordion Piccolo Stone Management DeviceThs International, Inc. D/B/A Accordion Medical

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑