510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K190492Substantially Equivalent

Peralta Stone Removal Catheter

Calcula Technologies, Inc., San Francisco CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K190492 is the FDA 510(k) clearance record for Peralta Stone Removal Catheter, a class II device, cleared for Calcula Technologies, Inc. on under FDA product code FFL (Dislodger, Stone, Basket, Ureteral, Metal). FDA records list one 510(k) clearance for Calcula Technologies, Inc. As of , FDA records show no recalls naming K190492.

Clearance record

Decision date
Received
(140 days to decision)
Product code
FFL Dislodger, Stone, Basket, Ureteral, Metal
Regulation
21 CFR 876.4680
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Calcula Technologies, Inc. 959 Peralta Ave., San Francisco CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FFL

Trailing 12 months

FDA records hold no clearances under product code FFL in the trailing twelve months.

FDA records show no clearances under product code FFL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FFL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260