510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K192811Substantially Equivalent

BenestaTM Tissue Removal Device

Caldera Medical, Inc., Agoura Hills CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K192811 is the FDA 510(k) clearance record for BenestaTM Tissue Removal Device, a class II device, cleared for Caldera Medical, Inc. on under FDA product code HIH (Hysteroscope (And Accessories)). FDA records list 24 510(k) clearances for Caldera Medical, Inc., from to . As of , FDA records show no recalls naming K192811.

Clearance record

Decision date
Received
(389 days to decision)
Product code
HIH Hysteroscope (And Accessories)
Regulation
21 CFR 884.1690
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Caldera Medical, Inc. 5171 Clareton Dr., Agoura Hills CA
510(k) summary
Statement
Third party review
No

Clearances, product code HIH

Trailing 12 months
8 clearances under product code HIH in the twelve months to October 2026, September 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code HIH, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20260
April 20260
May 20261
June 20261
July 20260
August 20261
September 20263
October 20260